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

Model Number WCD 4000

Device Problems Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device manufacture dates: battery: 11/15/2018, charger: 03/25/2011.Device evaluation of battery pack sn (b)(4) has been completed.The reported problem (battery faults) was confirmed.As received, the battery pack was unable to power a test monitor and charge.Upon evaluation, the nickel busbar tabs at the p2 & p4 pads were loose.The cause of the non-functional battery pack is the loose busbar.The root cause of the loose busbar cannot be positively identified.No adverse event resulted from the defective battery.Device evaluation of battery charger/modem sn (b)(4) has been completed.The reported problem (charger problem) has been confirmed.Upon investigation the battery charger/modem was unable to recharge a battery pack.The cause for the failure was contamination on the battery pca.The root cause for the contamination was ingress of an unknown liquid.Lifevest patient training materials have been updated as a reminder not to expose the lifevest electronic components to liquids.No adverse event resulted from the defective battery charger.

Event Description

A us distributor reported that a patient was receiving battery fault and had a charger problem.

• 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: 11091490
• MDR Text Key: 224346037
• Report Number: 3008642652-2020-11549
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005036
• UDI-Public: 00855778005036
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 10A0989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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