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

Model Number WCD 4000

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Death (1802); Loss of consciousness (2418); Shock from Patient Lead(s) (3162)

Event Date 07/20/2020

Event Type  Death  

Manufacturer Narrative

Device evaluation summary: the monitor sn (b)(4) and electrode belt sn (b)(4) have not been returned to the distributor for investigation.Device evaluation includes review of downloaded software flag files on the day of the event.The review of the software flags consisted of an analysis of the downloaded data to 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 treatment.Correction: event was analyzed.Device was returned for evaluation.Manufacture date: monitor - (b)(4) - 06/09/2014, belt - (b)(4) - 08/06/2018.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020.Review of the patient's download data reveals that the patient experienced an inappropriate defibrillation event consisting of one shock during asystole on (b)(6) 2020, the date of their passing.It was reported that the patient was unresponsive when found.The response buttons were not pressed during the event.Cpr/motion artifact and oversensing of low-amplitude cardiac signal contributed to the false detection.The patient was brought to a hospital by emergency medical services where it was reported that the lifevest was cut off the patient and cpr was performed.The patient subsequently passed away.There is no indication that the lifevest treatments during asystole caused or contributed to the death as, the patient was already in a non-life-sustaining rhythm.There is no indication or allegation that a device malfunction caused or contributed to the patient's passing.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: eliza schally ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10433757
• MDR Text Key: 203811108
• Report Number: 3008642652-2020-07223
• 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: Other
• Type of Report: Initial
• Report Date: 08/19/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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; Hospitalization; Other
• Patient Age: 74 YR