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

Model Number WCD 4000

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of battery sn (b)(4) has been completed.The reported problem (won't power up) has been confirmed.Upon investigation the battery was unable to recharge or power on a monitor.The fuse was open.The cause for the open fuse was excessive current.The root cause for the excessive current was unable to be positively identified.No adverse events occurred due to the defective battery.Device evaluation of charger sn (b)(4) were completed at the distributor.The reported problem (temperature) was confirmed.Upon start up, the charger began to smoke from the battery board.There was extensive corrosion found on the battery and bedside board causing the device to smoke.The root cause for the contamination was an 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 events occurred due to the defective battery charger.Mfg dates: battery pack sn (b)(4) - 9/27/2017.Battery charger sn (b)(4) - 11/23/2011.

Event Description

A us distributor reported that a patient's battery charger smelled like it was burning and that a battery was not powering up a monitor.

Manufacturer Narrative

Device evaluation of battery sn 86252495 been completed.The reported problem (will not power on monitor) has been confirmed.As received, the battery was unable to power on a monitor or charge.The battery pca and cells were contaminated.The root cause for the contamination was ingress of an unknown liquid.Lifevest patient instructions for use remind and warn patients not to expose the lifevest electronic components to liquids.No adverse events occurred due to the defective battery device evaluation of battery sn (b)(6) has been completed.The reported problem (won't power up) has been confirmed.Upon investigation the battery was unable to recharge or power on a monitor.The f1 fuse was open.The cause for the open fuse was excessive current.The root cause for the excessive current was unable to be positively identified.No adverse events occurred due to the defective battery.Device evaluation of charger sn (b)(6) were completed at the distributor.The reported problem (temperature) was confirmed.Upon start up, the charger began to smoke from the battery board.There was extensive corrosion found on the battery and bedside board causing the device to smoke.The root cause for the contamination was an 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 damaged charger.Mfg dates: battery pack sn (b)(6) - 9/27/2017.Battery charger sn (b)(6) - 11/23/2011.

Event Description

A us distributor reported that a patient's battery pack was unable to power on a monitor.A us distributor reported that a patient's battery charger smelled like it was burning and that a battery was not powering up a monitor.

• 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: landyn blinn ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 10727346
• MDR Text Key: 214538587
• Report Number: 3008642652-2020-09273
• 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: Literature,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: 09/24/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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