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

Model Number WCD 4000

Device Problem Cut In Material (2454)

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

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (wires exposed) has been confirmed.Upon investigation the cable connecting the distribution node (dn) to the rear therapy electrodes was pulled from the strain relief, damaging wires in the cable.The root cause for the strained cable was physical abuse.Device evaluation of battery charger/modem sn (b)(4) has been completed.The reported problem (charger faults) was confirmed.Upon investigation the charger exhibited a failure at pld component u1003 and pxa component u104 on the c/a board.Additionally, the q1 current-controlling transistor on the bedside pca was shorted.The root cause for the defective u1003 and u104 processors and the shorted q1 transistor could not be positively identified.No adverse event resulted from the defective electrode belt and battery charger/modem.----------------------------------------- device manufacture date: electrode belt sn (b)(4) - 10/19/2009, charger sn (b)(4) - 07/03/2013.

Event Description

A us distributor returned electrode belt sn (b)(4) and battery charger/modem sn (b)(4) for investigation.Wires were exposed on the electrode belt and the battery charger/modem was producing battery charger faults.

• 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: zachary nelson ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5786594
• MDR Text Key: 49954118
• Report Number: 3008642652-2016-04657
• Device Sequence Number: 1
• Product Code: MVK
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/16/2016
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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