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

Model Number WCD 4000

Device Problems Break (1069); Device Emits Odor (1425); Failure to Power Up (1476); Cut In Material (2454); Noise, Audible (3273)

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

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor (b)(4) has been completed.The reported problem (makes noise, smells hot, won't power on, damaged receptacle) was confirmed.As received, the monitor would not power on.Upon evaluation, the 1.8v and 3.3v power supplies were shorted in the u1003 pld component.The cause of the inability to power on is the shorted component.The root cause of the shorted u1003 cannot be positively identified.In addition, the belt receptacle and internal wires were confirmed to be damaged on the monitor.The cause of the inability to complete testing is the damaged receptacle and wires.The root cause of the damaged receptacle and wires is excessive force placed on the receptacle while an electrode belt was attached.No adverse event resulted from the damaged monitor.

Event Description

A us distributor returned a monitor indicating that it was 'making noises, smelled hot, and would not power on'.When a distributor representative visited the patient to replace the monitor, the representative noted that the belt connector appeared to be 'stuck' in the monitor receptacle.When the connector was pulled, the receptacle became damaged with exposed wires.

• 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: katelynn mains ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5886685
• MDR Text Key: 53349115
• Report Number: 3008642652-2016-05795
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/20/2016
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• 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