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

Model Number WCD 4000

Device Problem Insufficient Information (3190)

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

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

Electrode belt sn (b)(4) and monitor sn (b)(4) have been returned to the distributor, but have not been evaluated yet.Device evaluation included review of downloaded software flag files on the days surrounding the event.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction.

Event Description

A us distributor reported that a nurse called to allege that a patient was treated.The nurse reported that there was no blue gel on the patient.There is no evidence that the patient was treated.The download data, from the days surrounding of the alleged event, does not show any automatic events or flags indicating that a treatment or gel deployment occurred.Based on the available information, there is no indication of a treatment event.The occurrence of treatment is unable to be confirmed.This event is being reported out of an abundance of caution as a medical professional alleged the event and zoll is unable to positively determine if the defibrillation treatment occurred and if it was appropriate or inappropriate.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: brooke arnold ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10103750
• MDR Text Key: 193003889
• Report Number: 3008642652-2020-04827
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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: 05/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 67 YR