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

Model Number WCD 4000

Device Problem False Alarm (1013)

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

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (false asystole event) has been confirmed.Upon investigation the electrode belt failed an ecg fall-off test.The cause for the failure was isolated to a short in ecg "c".An unused pulse wire in the cable migrated into ecg electrode, causing a short.A root cause investigation determined that the cause of the unused wire migration in the ecg "c&d" cable was the lack of a method to secure the unused wire ends.No adverse event resulted from the defective equipment.

Event Description

A us distributor reported that a patient was experiencing false asystole alarms.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: eliza schally ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 9982930
• MDR Text Key: 188667427
• Report Number: 3008642652-2020-03407
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005012
• UDI-Public: 00855778005012
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2012
• 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