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

Model Number WCD 4000

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

The electrode belt sn (b)(4) was returned to the distributor and found to be fully functional.There is no indication of a device malfunction.Monitor sn (b)(4) was returned and evaluated at the distributor in accordance with procedures recommended by zoll manufacturing corporation.The reported problem (code 104) was confirmed.The cause for the failure was an ejected sd card.Upon investigation the monitor ecg acquisition and pulse delivery circuitry were tested and found to be fully functional.The root cause of the ejected sd card could not be positively identified.An ejected sd card does not affect the monitor's ability to detect and treat an arrhythmia.Unavailability of retrospective ecg recordings did not cause or contribute to the adverse event.The sd card is a data logger that only stores the patient's retrospective continuous ecg recordings.There is no real and active patient monitoring associated with the stored retrospective ecg recordings.

Event Description

A us distributor contacted zoll to report that a patient received a treatment event consisting of one shock at 14:34:04 on (b)(6) 2021.The patient's ecg rhythm at the time of the treatment is unknown.The patient was receiving sd card faults (service code 104) on the days surrounding the treatment event.The response buttons were pressed earlier in the detection sequence but not immediately prior to shock delivery.The response buttons functioned appropriately.The patient continued use of the lifevest.Reporting event out of an abundance of caution as the patient's rhythm at the time of treatment is unknown.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 12677411
• MDR Text Key: 277841152
• Report Number: 3008642652-2021-09338
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2014
• 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): Other