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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor has been completed.The reported problem (cannot run detect and treat testing due to functional issue) has been confirmed.Upon investigation the monitor was unable to power on.The cause for the failure was isolated to the defibrillator pca and computer/analog board.High voltage travelled to low voltage circuitry, damaging multiple components on the pcas.The root cause for the high voltage travelling to low voltage circuitry could not be positively identified.There was no adverse event that resulted from the damaged monitor.

Event Description

A us distributor returned a monitor and reported the monitor cannot run detect and treat testing due to a functional issue.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 16536913
• MDR Text Key: 311217505
• Report Number: 3008642652-2023-02413
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Date Manufacturer Received: 03/04/2023
• 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