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

Model Number WCD 4000

Device Problems Defibrillation/Stimulation Problem (1573); Communication or Transmission Problem (2896)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation of the monitor and electrode belt have been completed at the distributor.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.Upon investigation of the download data, the monitor had experienced multiple download communication faults, indicating an damaged sd card.An damaged sd card does not affect the monitor's ability to detect and treat an arrhythmia.Unavailability of retrospective ecg recordings did not cause or contribute to this adverse event.The sd card is a data logger that only stores the patient's retrospective continuous ecg recordings.There is no real and active patient monitoring associated with the stored retrospective ecg recordings.Inappropriate defibrillations are an anticipated risk associated with the use of the hospital wearable defibrillator.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest and hwd, can be found at (http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf).The zoll detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.

Event Description

A us distributor contacted zoll to report that a patient received three treatments from the lifevest.A review of the downloaded patient data flag files indicate that the patient received three unknown treatments at 18:51:28, 19:54:18, and 20:38:50 on (b)(6) 2021.The specific rhythm at the time of the treatment events is unknown.The downloaded data indicates that the device had download communication faults.There were no allegations of device malfunction.The device was fully functional upon receipt.Reporting this event out of an abundance of caution as the rhythm at the time of the treatment event 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: mary ward ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13428366
• MDR Text Key: 284974854
• Report Number: 3008642652-2022-01240
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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): Other