MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problems Device Alarm System (1012); Defibrillation/Stimulation Problem (1573)

Patient Problem Death (1802)

Event Date 05/18/2015

Event Type  Death  

Event Description

A us distributor reported that an (b)(6) year old male patient passed away on (b)(6) 2015 while wearing the lifevest.The patient was in a rehabilitation center at the time of the event.The patient's nurse stated that the lifevest did not alarm, and that the patient went into asystole.Rehabilitation staff attempted to resuscitate the patient with cpr and medication but the efforts were unsuccessful.The lifevest detected very brief arrhythmias at 12:29:58 and 12:32:43.The first arrhythmia detection lasted approximately two seconds and the second arrhythmia detection lasted approximately five seconds, at which point a normal rhythm was detected.The arrhythmia detections were not sustained long enough to complete the lifevest treatment sequence.Asystole was detected by the lifevest beginning at 12:59:17.Asystole is considered a non-treatable rhythm.The patient's ecg rhythm at the time of the event is not available for review.

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) was completed.The electrode belt was fully functional upon receipt.Device evaluation of monitor sn (b)(4) was completed.The ecg strips of the event could not be recovered due to an sd card fault.As such, the exact rhythm at the time of the lifevest arrhythmia declarations could not be determined.Since zoll cannot definitively confirm that the patient was not in a treatable arrhythmia, zoll is reporting this event out of an abundance of caution.The sd card fault did not preclude the device's ability to detect an arrhythmia and deliver a treatment defibrillation.Root cause investigation into the sd card fault is underway.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 349
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 349
• Manufacturer Contact: zachary nelson ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4883668
• MDR Text Key: 6266059
• Report Number: 3008642652-2015-04198
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR