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

Model Number WCD 4000

Device Problems Self-Activation or Keying (1557); Noise, Audible (3273)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

A (b)(6) male pt contacted zoll customer support to report that his monitor was making a weird sound and was resetting.The pt was issued a replacement monitor.

Manufacturer Narrative

Device eval summary: device eval of monitor sn (b)(4) has been completed.The reported problem (monitor resetting, system speaker hums) have been confirmed.As received, the monitor would not fully power on.The cause of the inability to fully power on was a flash memory failure (components u102 and u105) on the c/a board.The flash memory has an intermittent connection.The intermittent connection was likely induced by mechanical stress.The exact source of the mechanical stress has not be positively identified but the intermittent connection may have been accelerated through rough handling.A root cause investigation for the fracture is currently underway.No adverse event resulted from the defective monitor.The pt received a replacement monitor.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL LIFECOR CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: lindsey folio ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 3829085
• MDR Text Key: 15329835
• Report Number: 3008642652-2014-01376
• 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: Other
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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 Age: 66 YR