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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Dizziness (2194)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

There was no death associated with the inappropriate defibrillation event.There is no indication that the patient sustained a serious injury.Device evaluation summary: monitor sn (b)(4) and belt sn (b)(4) have not yet been recovered.Initial evaluation included a review of downloaded software flag files (attached) 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.Device manufacture date: monitor: 09/06/2013, belt: 07/28/2014.The investigation into the event concludes that there was no device malfunction contributing to the treatment event.A cause and effect analysis was conducted (attached) using all of the available information which includes the incident report, device evaluation, software flag files, and ecg strips (attached).The primary cause of the inappropriate shock was lack of response button use (patient error).The ecg analysis, conducted by trained ecg technicians, identified the primary cause of the false detection was ecg motion artifact.The source of the motion artifact could not be positively identified through the cause and effect analysis.The following factors could not be ruled out as contributing causes of the motion artifact: body motion, poor ecg contact with skin.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.(b)(4).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 .The lifevest detection algorithm complies with (b)(4) performance requirements for sensitivity and specificity.(b)(4).

Event Description

A us distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event.The patient was reportedly getting out of his car during the event.The patient laid in the driveway and felt dizzy for a few minutes following the shock.Motion artifact contributed to the false detections.Review of the download data indicates that the response buttons were not pressed during the event.There is no indication that the patient required medical attention following the event.The patient continued 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 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: 6356737
• MDR Text Key: 68267291
• Report Number: 3008642652-2017-01180
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 02/08/2017

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?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2013
• 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): Other
• Patient Age: 67 YR