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

Model Number WCD 4000

Device Problem Failure to Power Up (1476)

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

Event Date 06/30/2015

Event Type  malfunction  

Event Description

A us distributor returned battery sn (b)(4) and reported that the battery was unable to power on a monitor.

Manufacturer Narrative

Device evaluation of battery sn (b)(4) is underway.The reported problem (will not power on monitor) has been confirmed.Upon investigation the battery was unable to power on a monitor or charge.The battery is being returned to the supplier for root cause investigation.A supplemental report will be submitted upon completion.No adverse event resulted from the defective battery.

Manufacturer Narrative

Device evaluation of battery sn (b)(4) was completed.Per the battery supplier, the cause for the battery failure was defective battery tri-cells.The root cause for the defective cells could not be positively identified.No adverse event resulted from the defective battery.

Event Description

A us distributor returned battery sn (b)(4) and reported that the battery was unable to power on a monitor.

• 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: zachary nelson ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4946329
• MDR Text Key: 6192992
• Report Number: 3008642652-2015-04654
• Device Sequence Number: 1
• Product Code: MVK
• 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,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• 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: 06/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2014
• 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