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

Model Number WCD 4000

Device Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

There was no death associated with the alleged event.No information to suggest the patient sustained a serious injury.Device evaluation summary: electrode belt sn (b)(4) was returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the inappropriate treatment.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.The pulse delivery circuitry test verified proper delivery of a full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.Device evaluation of monitor sn (b)(4) has been completed.The reported problem (treatment) is unable to be confirmed.As received, the monitor would not power on.Upon evaluation, there were multiple components damaged on the computer / analog (ca) board and defibrillator board.The cause of the inability to power on is the damaged components.The cause of the damaged components is high voltage deviation to low voltage circuitry.The primary cause of the shock event is unknown due to the loss of ecg and flag data.The primary cause of the detection is unknown due to the loss of ecg data.

Event Description

A us distributor contacted zoll to report that a patient experienced a defibrillation event on (b)(6) 2018.A nurse at the skilled nursing facility where the patient was staying reported that the device had released gel and the patient could have been treated.A distributor field support services representative attempted to send a data download but the device was not powering on.It is unclear when the device stopped being able to power on.Following the alleged event, the patient remained in the skilled nursing facility and continued wearing the lifevest.The ecg and flag data surrounding the alleged treatment was unavailable for review due to thermal damage within the monitor.The occurrence of treatment is unable to be confirmed.This event is being reported out of an abundance of caution as zoll is unable to positively determine if the defibrillation treatment occurred and if it was appropriate or inappropriate.There was no death associated with the defibrillation event.

• 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: manuela parra ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8033832
• MDR Text Key: 125982780
• Report Number: 3008642652-2018-09359
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• 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: 10/03/2018
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR