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 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (delivers monophasic pulse) has not been confirmed.Upon investigation the monitor's flag reports do not indicate that the monitor delivered a monophasic pulse and it was unable to be duplicated.It was determined that the monitor was unable to run the detect and treat testing due to service code 204.The cause for service code 204 is a shorted pin 3 on component u409.During the evaluation, it was found that service code 105 was displayed.The cause for the failure was isolated to the defibrillator pca and computer/analog board, where high voltage travelled to low voltage circuitry, damaging multiple components (q2 and q16) on the pcas.The root cause for the shorted component u409 could not be positively identified.The root cause for the high voltage travelling to low voltage circuitry could not be positively identified.No adverse event resulted from the defective monitor.

Event Description

A us distributor returned a monitor for an unrelated problem and during the investigation a reportable malfunction was found.

• 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: eliza schally ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 9349655
• MDR Text Key: 175095787
• Report Number: 3008642652-2019-09178
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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: 10/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• 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