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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Device Displays Incorrect Message (2591)

Patient Problems Syncope (1610); Death (1802)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: belt sn (b)(4) was returned to the distributor where it was scrapped due to a biohazard.The device is not available for further evaluation.Review of the available download data does not indicate any device malfunction contributing to the event.Monitor sn (b)(4) was returned to zmc where it passed incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the device, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the audio messaging and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no evidence to suggest that the lifevest caused or contributed to the patient's death.The patient was in svt when the device was shutdown.The patient had been responding appropriately to the false detections prior to the device being shutdown.

Event Description

A us distributor contacted zoll to report that a lifevest patient passed away on (b)(6) 2016 between 5am and 8am.The distributor support services had spoken with the patient earlier the same morning.The patient reported multiple arrhythmia alarms for which he was pressing the response buttons, but indicated that he intended to remove the device.Distributor support services cautioned the patient in doing so and advised to continue to wear the device and continue to press the response buttons as long as he is receiving the alarms and is conscious.The patient reported that he was breathing heavy and was a 'little light headed' but felt fine.Review of the download data indicates that the patient was receiving arrhythmia alarms due to false detections.Svt between 180bpm and 190bpm contributed to the false detections.The device was shut down on (b)(6) 2016 at 3:52:55am while the patient was in svt at 190bpm.The exact time of the patient's death is unknown.

• 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: 5611889
• MDR Text Key: 44474970
• Report Number: 3008642652-2016-02821
• 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: 04/27/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2012
• 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 Outcome(s): Death
• Patient Age: 64 YR