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

Model Number WCD 4000

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Death (1802)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: device evaluation of electrode belt sn (b)(4) has been completed.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.There is no indication that the damaged electrode belt contributed to the prior patient's passing.Review of the downloaded software flag data revealed no fault flags or patters of flags indicating that the damage to the electrode belt occurred prior to device removal.The damage to the electrode belt is consistent with damage observed during the removal of the device during resuscitation attempts.No adverse event resulted from the defective electrode belt.

Event Description

While evaluating electrode belt sn (b)(4) for an unrelated issue, a reportable problem was found.The cable connecting the distribution node and rear therapy electrodes was pulled from the strain relief.The belt was last used by a patient who passed away while using the lifevest.The patient was in asystole, which is considered a non-shockable rhythm.There is no indication that the damaged belt contributed to the patient passing.The damaged is consistent with damage observed during the removal of the device during resuscitation efforts.

• 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: allison petzold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7133160
• MDR Text Key: 95534627
• Report Number: 3008642652-2017-10671
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005012
• UDI-Public: 00855778005012
• 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: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 11/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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