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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Battery Problem (2885); Key or Button Unresponsive/not Working (4063)

Patient Problems Lethargy (2560); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor has been completed.The reported problem (response buttons non-functional) due to the rear response button trace was damaged.The root cause of the damaged trace cannot be positively identified.There was no adverse event that resulted from the damaged monitor.

Event Description

A us distributor returned a monitor and reported that the response buttons were non-functional.

Manufacturer Narrative

Device evaluation of battery pack has been completed.The reported problem (will not power up) was confirmed.As received, the battery was unable to power on a monitor or charge.The cause for the failure was isolated to a loose bus bar inside of the battery.The root cause of the loose busbar cannot be positively identified.No adverse event resulted from the damaged battery.Device evaluation of monitor has been completed.The reported problem (response buttons non-functional) due to the rear response button trace was damaged.The root cause of the damaged trace cannot be positively identified.There was no adverse event that resulted from the damaged monitor.

Event Description

A us distributor reported that a battery would not power on a monitor.A us distributor returned a monitor and reported that the response buttons were non-functional.

• 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: 18171929
• MDR Text Key: 328552642
• Report Number: 3008642652-2023-11812
• 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,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2023
• 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