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

Model Number WCD 4000

Device Problem Device Stops Intermittently (1599)

Patient Problem Death (1802)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: device evaluation of monitor sn (b)(4) has been completed.The reported problem (intermittent response buttons) has been confirmed.Upon evaluation, the response buttons were intermittent.The cause of the non-functional response buttons is a damaged rear response button cable.The root cause of the damaged cable cannot be positively identified.There is no indication that the malfunction contributed to the patient death.

Event Description

During servicing of monitor sn (b)(4) , which was returned for investigation into a patient's death, a reportable device malfunction was found.The monitor's response buttons were intermittent.The device failure did not cause or contribute to the patient's death.The patient was in sinus rhythm at 90 beats per minute at the time of device shutdown prior to the patient's death.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: johnna dominick ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 6142192
• MDR Text Key: 61608631
• Report Number: 3008642652-2016-08874
• 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: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1