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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Circuit Failure (1089); Structural Problem (2506); Battery Problem (2885)

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

Event Date 05/21/2023

Event Type  malfunction  

Event Description

A us distributor reported that a battery was unable to power on a monitor.A us distributor reported that a patient's electrode belt's cable was damaged.

Manufacturer Narrative

Device evaluation of electrode belt has been completed.The reported problem (damaged cable) was isolated to the cable connecting the distribution node (dn) to the rear-1 therapy electrodes being pulled from the strain relief, damaging wires in the cable.The belt did not pass detect and treat testing.The root cause for the strained cable was excessive force.There was no adverse event that resulted from the damaged belt.Device evaluation of battery pack has been completed.The reported problem (will not power up) was confirmed due to a loose bus bar inside of the battery.The root cause of the loose busbar cannot be positively identified.There was no adverse event that resulted from the damaged battery.

Manufacturer Narrative

Device evaluation of monitor has been completed.Upon investigation the monitor was unable to communicate.The cause for the failure was isolated to a missing sd card.The root cause for the missing sd card could not be positively identified.No adverse event resulted from the damaged monitor.Device evaluation of electrode belt has been completed.The reported problem (damaged cable) was isolated to the cable connecting the distribution node (dn) to the rear-1 therapy electrodes being pulled from the strain relief, damaging wires in the cable.The belt did not pass detect and treat testing.The root cause for the strained cable was excessive force.There was no adverse event that resulted from the damaged belt.Device evaluation of battery pack has been completed.The reported problem (will not power up) was confirmed due to a loose bus bar inside of the battery.The root cause of the loose busbar cannot be positively identified.There was no adverse event that resulted from the damaged battery.

Event Description

A us distributor returned a monitor and reported being unable to complete incoming functional testing.A us distributor reported that a battery was unable to power on a monitor.A us distributor reported that a patient's electrode belt's cable was damaged.

• 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: 17207985
• MDR Text Key: 317908785
• Report Number: 3008642652-2023-06306
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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: 06/26/2023
• 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