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

Model Number WCD 4000

Device Problem Self-Activation or Keying (1557)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) is underway.The reported problem (resets) has been confirmed.Upon investigation the monitor reset after delivering a pulse during incoming functional testing.A root cause investigation is underway.A supplemental report will be submitted upon completion of the root cause investigation.Investigation underway.No adverse event resulted from the defective monitor.

Event Description

A us distributor reported that a monitor was resetting.

Manufacturer Narrative

Device evaluation of monitor has been completed by engineering.The reported problem (resets) has been confirmed.Upon investigation the monitor reset during a pulse test.The cause for the failure was isolated to defective t2 transformers on the defibrillator pca.The root cause for the defective transformer could not be positively identified.No adverse event resulted from the defective monitor.Device evaluation of monitor sn 07177838 is underway.The reported problem (resets) has been confirmed.Upon investigation the monitor reset after delivering a pulse during incoming functional testing.A root cause investigation is underway.A supplemental report will be submitted upon completion of the root cause investigation.Investigation underway.No adverse event resulted from the defective monitor.

Event Description

A us distributor reported that a monitor was resetting.A us distributor reported that a monitor was resetting.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 11108813
• MDR Text Key: 226076889
• Report Number: 3008642652-2020-11678
• 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,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• 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