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

Model Number WCD 4000

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.Upon evaluation, the monitor exhibited an intermittent flash memory failure at bga components u102 and u105 on the computer/analog board sn (b)(4).The root cause for the flash memory failure could not be positively identified.No adverse event resulted from the defective monitor.

Event Description

During investigation of an unrelated problem, it was found that a monitor had an intermittent flash memory failure.

• 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: manuela parra ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7386704
• MDR Text Key: 104045329
• Report Number: 3008642652-2018-03016
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• 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: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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