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

Model Number WCD 4000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bone Fracture(s) (1870); Shock from Patient Lead(s) (3162)

Event Date 04/04/2021

Event Type  Injury  

Manufacturer Narrative

Monitor sn (b)(4) and electrode belt sn (b)(4) were returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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 inappropriate treatment.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 of the device.Device manufacture date: monitor 07/10/2013.Belt 02/13/2018.

Event Description

A us distributor contacted zoll to report that a patient was treated by the lifevest on (b)(6) 2021.It was reported that the patient might have blacked out and got in a car accident.It was reported that the patient sustained broken bones as a result of the car accident.The patient received medical attention for their injuries at the hospital and was recovering.The patient ended use of the lifevest and received an icd.Per clinical review of the ecg's, the patient received one appropriate treatment and one inappropriate treatment during the event.The lifevest detected an arrhythmia while the patient was in vt at 250 bpm at 21:01:04.The patient received the appropriate treatment at 21:01:39.The patient's rhythm at the time of treatment was vt at 250 bpm.The patient's post-shock rhythm was af with rvr at 150 bpm with frequent pvc's.The patient received the inappropriate treatment at 21:02:11.The patient's rhythm at the time of treatment was af with rvr at 190 bpm.The patient's post-shock rhythm was sinus tachycardia at 130 bpm with pvc's.Af with rvr contributed to the inappropriate treatment.The response buttons were pressed after the treatment was delivered.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 11844916
• MDR Text Key: 251368420
• Report Number: 3008642652-2021-04143
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• 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
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 39 YR