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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (gong alarms/ arrhythmia alarms, false asystole events) has been confirmed.Upon investigation the electrode belt failed an ecg fall-off test.The cause for the failure was isolated to an open brown (-5v) wire in the trunk cable.The trunk cable showed signs of physical abuse.The root cause for the open wire was excessive force.No adverse event resulted from the defective electrode belt.

Event Description

A us distributor returned a patient's electrode belt and reported that the patient was experiencing false asystole events, gong alarms, and arrhythmia alarms.

• 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: mary ward ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 11298298
• MDR Text Key: 232082190
• Report Number: 3008642652-2021-01168
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005135
• UDI-Public: 00855778005135
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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: 10A1025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2011
• 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