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

Model Number WCD 4000

Device Problems Device Emits Odor (1425); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluations of battery charger sn (b)(4) and battery pack (b)(4) have been completed.The reported problem (burning smell / does not charge) was investigated.Upon evaluation of the charger, there was contamination on the battery board and the u13 processor, q1 transistor, and d2 diode were shorted on the bedside pca board.The cause of the inability to properly charge the battery packs is the contamination and shorted components.The cause of the shorted components is the contamination.The root cause of the contamination is liquid ingress of an unknown contaminant.Upon evaluation of the battery pack, there was contamination on the pca board.The cause of the burning smell and inability to charge is the contamination.The root cause of the contamination is liquid ingress of an unknown contaminant.Lifevest patient training materials have been updated as a reminder not to expose lifevest electronic components to liquid.No adverse event resulted from the defective battery charger or battery pack.

Event Description

A us distributor contacted zoll to report that a 'strong burning smell' was coming from the battery pack and that the charger would not charge the battery packs.

• 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: katelynn mains ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8418101
• MDR Text Key: 138778087
• Report Number: 3008642652-2019-01763
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2012
• 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