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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

A us distributor reported that a patient's battery charger is smoking and the battery is charred.

Manufacturer Narrative

Device evaluation of battery charger was completed.The reported problem (charger is smoking) was confirmed.Upon investigation, the charger was unable to charge/recognize a battery.The failure was isolated to a burned battery board.The root cause of the burned battery board was unable to be positively identified.There was no adverse event that resulted from the damaged battery charger.

Manufacturer Narrative

The battery pack sn (b)(6) evaluation has been completed.The reported problem (battery charred) was confirmed.Upon investigation there was thermal damage to the outside of the battery caused by an outside source.There was no internal thermal damage to the battery.The thermal damage did not affect the essential performance of the battery.During investigation of the battery pack sn (b)(6), a reportable malfunction was found.The battery pack was unable to recharge or power on a monitor.The f1 fuse was open and there is a loose busbar inside of the battery.The cause for the open fuse was excessive current.The root cause for the excessive current cannot be positively identified.The root cause for the loose busbar cannot be positively identified.No adverse event resulted from the damaged battery.Device evaluation of battery charger was completed.The reported problem (charger is smoking) was confirmed.Upon investigation, the charger was unable to charge/recognize a battery.The failure was isolated to a burned battery board.The root cause of the burned battery board was unable to be positively identified.There was no adverse event that resulted from the damaged battery charger.

Event Description

During investigation of the battery pack sn (b)(6), a reportable malfunction was found.A us distributor reported that a patient's battery charger is smoking and the battery is charred.

• 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: 15304326
• MDR Text Key: 298724482
• Report Number: 3008642652-2022-22828
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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: 09/01/2022
• 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