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

Model Number WCD 4000

Device Problem Device Inoperable (1663)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 04/05/2015

Event Type  Death  

Manufacturer Narrative

Device evaluation summary: zoll's attempts to recover the patient's monitor and electrode belt have been unsuccessful.Monitor sn 07057376 and electrode belt sn (b)(4) have not yet been returned to zoll.The last data download was on (b)(4) 2015 at 2:15 am.There are no downloaded software flags from around the time of death.An analysis of the available downloaded data did not identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the patient death.There is no indication at this time that the device caused or contributed to the patient passing.

Event Description

During a retroactive review of distributor incident files, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.The patient's sister reported that the patient passed away on (b)(6) 2015.It was reported that the passing was cardiac related and that the patient went into cardiac arrest.She reported that the lifevest did not work and that ems would not perform cpr because the lifevest was on.The patient's sister reported that she begged them to take the lifevest off and to start cpr but ems would not.The patient was reportedly at home putting away groceries prior to the event.She was later transported to and passed away at the hospital.It was reported that the lifevest did alarm but the patient had already passed.

• 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: allison petzold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5054524
• MDR Text Key: 24979904
• Report Number: 3008642652-2015-05267
• 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
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• 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 Outcome(s): Death
• Patient Age: 46 YR