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

Model Number WCD 4000

Device Problems Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 06/29/2017

Event Type  Death  

Manufacturer Narrative

The monitor sn (b)(4) and electrode belt sn (b)(4) were returned to zmc for evaluation.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, 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 tactile vibration alarm, 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 indication of a product malfunction.

Event Description

A us distributor contacted zoll to report that a patient was treated prior to passing away on (b)(6) 2017 at 10:40pm.The patient's husband reported that at the time of the event, the device was alarming but never treated the patient and that he performed cpr on the patient.Per review of the event, confirms that the patient was treated once on (b)(6) 2017.While monitoring the patient on the evening of (b)(6) 2017, the device first alarmed for an arrhythmia at 10:24:38 pm.The ecg recording showed that the patient was in poly-morphic vt at 150 bpm.The response buttons were pressed multiple times approximately 11 seconds after the alarms began, preventing a treatment from being delivered.The device alarmed for a second time at 10:25:01pm.The ecg recording showed coarse vf with motion artifact transitioning to cpr artifact, preventing a treatment from being delivered.At 10:30:11 pm, the lifevest alarmed for the third time and delivered a treatment shock at 10:30:54 pm.The underlying rhythm at the time of the treatment and post-shock is unknown due to the presence of cpr artifact on the ecg channels.The cpr artifact contributed to the false detection.A fourth arrhythmia alarm began at 10:31:35.The ecg recording showed bradycardia at 50 bpm with nsvt.The device recognized a non-treatable rhythm and not treatment was delivered.At 10:33:02 a fifth arrhythmia alarm began.The ecg recording revealed poly-morphic vt at 180 bpm and cpr artifact.The response buttons were pressed multiple times 15 seconds after the alarm began, preventing a treatment from being delivered.The final arrhythmia alarm commenced at 10:36:51 pm.The ecg recordings revealed cpr artifact.The response buttons were pressed and the electrode belt was disconnected 43 seconds later.The lifevest appropriately detected vt and vf, however, use of response buttons and cpr artifact prevented treatment during the tachyarrhythmias.

• 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: 6788055
• MDR Text Key: 82482531
• Report Number: 3008642652-2017-06632
• 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: 08/08/2017

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: 07/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2016
• 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: 51 YR