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

Model Number WCD 4000

Device Problems Device Alarm System (1012); Defibrillation/Stimulation Problem (1573)

Patient Problem Ventricular Tachycardia (2132)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Monitor sn (b)(4) and belt sn (b)(4) were returned and evaluated at the distributor in accordance with procedures recommended by zoll manufacturing corporation.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.Device manufacture date: monitor - 02/01/2018, belt - 05/26/2015.

Event Description

A us distributor contacted zoll to report that a patient's nurse reported that the patient entered vt for approximately two minutes and the lifevest did not alarm.The staff reportedly had to externally defibrillate the patient.It was reported that the battery may not have had charge at this time.Review of the download data indicates that the lifevest was powered down normally at 11:41:49.There is no indication that the battery did not have charge during this time.There are no runtime expired events and the device was shutdown normally.Review of the downloaded data indicates that the patient entered vt at 13:13:59.No treatment sequence was initiated as the patient's morphology during this time too closely matched the morphology of the patient's baseline recording.The device did detect vt at 180bpm at 14:34:59.The response buttons were pressed during the detection.It is unknown who pressed the response buttons.The lifevest delivered an appropriate treatment shock at 14:37:44 that converted vf.The rhythm following the shock was a 10 second pause with spontaneous return of bradycardia at 20bpm.There is no death associated with the event.The patient ended use and went to a hospice facility.

• 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: 8143385
• MDR Text Key: 129667696
• Report Number: 3008642652-2018-10347
• 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: 12/07/2018

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?: Yes
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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): Required Intervention
• Patient Age: 60 YR