More Information on Device Recalls

More Information on the Welch Allyn AED

Letter About Defective Welch Allyn AEDs

March 13, 2009

Frank Torti, M.D., M.P.H.
Acting Commissioner, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Torti,

On February 26, Welch Allyn initiated a Class 1 recall of 14,054 of its automatic external defibrillators (AEDs), the largest of a total of six recalls of these dangerously problematic devices to date.[1] Yet, as of this morning, the Food and Drug Administration has not announced this imminent threat to the American public. AEDs are life-saving devices typically used by emergency responders and hospital personnel to resuscitate patients in cardiac arrest. This recall is particularly alarming given it is the latest in a series of recalls of defective Welch Allyn AEDs, a category of devices under-regulated by the FDA (see regulatory status below). How many more deaths and near deaths because of delays in resuscitation will have to occur before the FDA takes more definitive action to end the use of these all-too-often defective Welch Allyn devices?

Class 1 recalls are the most serious type of recall, involving situations in which there is a reasonable probability that using the product will cause serious injury or death. Welch Allyn acknowledges two deaths have been associated with problems identified in this current recall.[2] According to the FDA website,[3] in January 2008, a patient died after the AED 10 shutdown in the middle of resuscitation. Then, in November 2008, a patient died after an AED 10 failed to shock during resuscitation.

This current recall is for the following problems listed in Table 1, each affecting varying numbers of the total 14,054 units recalled. According to Welch Allyn, these problems “may prevent defibrillation of a patient in cardiac arrest and could lead to death.”1 In other words, the company is admitting that the problems listed below could prevent the defibrillator from functioning properly and thus impair its ability to prevent someone with ventricular fibrillation from dying.

Table 1. Problems with AED 10 and MRL JumpStart defibrillators in 2009 class I recall

Problem

Affected

units

Date manufactured

Serious injury or death reported by Welch Allyn

Voice prompt failure

5,336

Oct 3, 2002- Jul 26, 2004

No

Unexpected shutdown

10,735

Oct 3, 2002- Dec 30, 2004

11 incidents, 1 death

Inappropriate shock or appropriate shock not delivered

10,735

Oct 3, 2002- Dec 30, 2004

8 incidents

Low energy shock

14,012

Oct 3, 2002-Jul 11, 2005

20 incidents, 1 death

Blown fuse

4,568

May 18, 2004- Dec 30, 2004

No

Shutdown in cold weather

89

Received software upgrade in 2007

No

Since 2005, Welch-Allyn’s AEDs have been the focus of five previous Class 1 recalls, including a recall of AED 10s in October 2007.[4],[5],[6],[7],[8] In four instances, the recall has been due to an intermittent electrical connection within the AEDs that can cause a ‘Defib Comm’ error message to appear, leading to inability to analyze patients’ electrocardiograms (ECG) and provide appropriate defibrillation. This malfunction has been associated with at least two deaths.3 Given multiple instances of recalls for the same problem, Welch Allyn appears unable to capture all of the affected devices in their recalls. The recalls are summarized in the Table 2.

Table 2. Previous recalls of Welch Allyn AEDs

Model

Date recall initiated

Date recall posted

Class

Reason

Affected units

Patient complaints

AED 10

Oct 26, 2007

Nov 6, 2007

1

Delay or non-delivery of the defibrillating shock due to defective capacitor

1,795

49 failures and 3 customer complaints

AED 20

Aug 24, 2007

Sep 19, 2007

1

Failure of the device to analyze ECG*

1,637

21 complaints received

PIC 50

Nov 15, 2006

Jan 19, 2007

2

Shock delay (due to ‘ECG Comm’ error message)

510

 

PIC 50

Jun 30, 2006

Jul 8, 2006

1

Failure of the device to analyze ECG*

1,184

18 related complaints, with 2 instances of delayed resuscitation

AED 20

Jun 15, 2006

Jun 22, 2006

1

Failure of the device to analyze ECG*

580

30 related complaints, with one instance of delayed resuscitation

AED 20

Apr 28, 2005

May 12, 2005

1

Failure of the device to analyze ECG*

597

12 related complaints and 1 death

AED 10

Apr 26, 2004

Jul 20, 2004

2

Intermittent shock button failure

460

 

*Due to ‘Defib Comm’ error message. This problem occurs because of an intermittent electrical connection within the device. This problem was identified in multiple  previous recalls.

Regulatory status: Automatic external defibrillators

Moreover, this latest recall once again makes it clear that the entire category of AEDs, a class III medical device, is insufficiently regulated by the FDA. Class III devices are life-supporting, life-sustaining, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.[9] Because of their risk, class III devices are to be regulated under the PMA (premarket approval) pathway; this requires direct evidence of safety and effectiveness before being marketed.[10] However, because the FDA has failed to meet statutory requirements established in 1990, AEDs, and a handful of other class III devices, are still regulated under a less-stringent premarket review mechanism, the 510(k) pathway.[11] Thus, the amount of data, specifically clinical data, submitted by manufacturers prior to marketing AEDs is sparse.[12]

Therefore there is minimal data concerning the technical performance of AEDs.[13] Moreover, the number of advisories (recalls and safety alerts) and the number of devices affected by these advisories increased between 1996-2005.13 Given their inappropriate regulation under 510(k), this is cause for great concern.

We request a timely response to the following questions: How are manufacturers deciding which devices are affected and are subject to the recall? Moreover, why has the FDA not announced this recall? Furthermore, why is the FDA permitting manufacturers to continue to introduce these potentially life-saving devices with only minimal data through the 510(k) pathway? Lastly, why has the FDA not taken further measures to address what is an obviously deficient device manufacturer?

Sincerely,

Sidney M. Wolfe, M.D., Director

Jonas Hines, Researcher
Health Research Group at Public Citizen


[1] Welch Allyn. Welch Allyn issues voluntary recall of select AED 10 Defibrillators. March 11, 2009. www.welchallyn.com/pressroom/releases/2009/AED10_Recall_03-10-2009.htm. Accessed March 13, 2009.

[2] Welch Allyn. Welch Allyn AED 10 recall information www.welchallyn.com/support/customer/AED_lookup.jsp. Accessed March 13, 2009.

[3] Food and Drug Administration. Search MAUDE database.  Updated February 28, 2009. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm. Accessed March 13, 2009.

[4] Food and Drug Administration. Class 1 recall; Welch Allyn AED 10 Automatic External Defibrillators. October 26, 2007 http://www.fda.gov/cdrh/recalls/recall-102607.html. March 13, 2009.

[5] Food and Drug Administration. Class 1 recall; MRL/Welch Allyn AED 20 Automatic External Defibrillators. August 24, 2007 http://www.fda.gov/cdrh/recalls/recall-082407.html. Accessed March 13, 2009.

[6] Food and Drug Administration. Class 1 recall; Welch Allyn PIC 50 Automated External Defibrillators. June 30, 2006. http://www.fda.gov/cdrh/recalls/recall-063006.html. Accessed March 13, 2009.

[7] Food and Drug Administration. Class 1 recall; Welch Allyn AED 20 Automated External Defibrillators. June 15, 2006. http://www.fda.gov/cdrh/recalls/recall-061506.html. Accessed March 13, 2009.

[8] Food and Drug Administration. Class I recall; Welch Allyn AED 20 Automatic External Defibrillator. April 28, 2005. http://www.fda.gov/cdrh/recalls/recall-042805.html. Accessed March 13, 2009.

[9] 21 U.S.C. § 360c(a)(1)(C).

[10] Food and Drug Administration. Guidance on the CDRH premarket notification review program (k86-3). June 30, 1986. www.fda.gov/cdrh/k863.html. Accessed March 13, 2009.

[11] United States Government Accountability Office. Medical devices; FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process; Report to Congressional addressees. January 2009. www.gao.gov/new.items/d09190.pdf. Accessed March 11, 2009.

[12] Kessler L, Ramsey SD, Tunis S, Sullivan SD. Clinical use of medical devices in the 'Bermuda Triangle'. Health Affairs (Millwood). 2004;23(1):200-7.

[13] Shah JS, Maisel WH. Recalls and safety alerts affecting automated external defibrillators. Journal of the American Medical Association. 2006;296(6):655-60.

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