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

Model Number WCD 4000

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670)

Patient Problems Syncope (1610); Fall (1848); Shock from Patient Lead(s) (3162)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

There was no death or device malfunction associated with the inappropriate defibrillation event.Electrode belt sn (b)(4) was returned to the distributor, but has not been evaluated yet.Device evaluation included review of downloaded software flag files on the day of the event.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.Monitor sn (b)(4) was 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.The pulse delivery circuitry test verified proper delivery of a full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.For treatment: the investigation into the event concludes that there was no device malfunction.A cause and effect analysis was conducted using all of the available information which includes the incident report, device evaluation, software flag files, and ecg strips.The primary cause of the inappropriate shock was lack of response button use prior to the treatment shock (patient error).The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was af with rvr.The rapid rate satisfied the rate detector of the detection algorithm.For head injury: per the incident, the patient fell and hit their head during the treatment event.The patient reported no sustained injuries from the fall.Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0.69%per patient-month with 90% confidence).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf.The lifevest 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 experienced an inappropriate defibrillation event consisting of one shock.The patient was sitting at the grocery store and had a syncopal episode at the time of the treatment event.The response buttons were not pressed during the treatment event.Atrial fibrillation (af) with rapid ventricular response (rvr) contributed to the false detection.The patient also reported that he fell and hit his head during the treatment event.The patient did not indicate any sustained injuries or medical intervention for their head.The patient was in the hospital and refused to wear the lifevest, he instead decided to end use of the lifevest.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: matthew saich ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10196700
• MDR Text Key: 200664825
• Report Number: 3008642652-2020-05348
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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?: No
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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): Hospitalization; Other
• Patient Age: 82 YR