BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4792578 · Received May 20, 2015

    Report

    Report Number
    3008642652-2015-03347
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATIONS. DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (FAILED INCOMING FUNCTIONALITY TESTING HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR DISPLAYED A SVC CODE 203 (PULSE TEST FAILURE). THE CAUSE FOR THE FAILURE WAS ISOLATED TO CORROSION ON THE J1002 AND J1003 CONNECTORS BETWEEN THE COMPUTER/ANALOG AND DEFIBRILLATOR PCAS. THE ROOT CAUSE FOR THE CORROSION WAS INGRESS OF AN UNK LIQUID. THERE IS NO INDICATION THAT THE CONTAMINATED MONITOR CONTRIBUTED TO THE TREATMENT EVENT AS THE DEVICE WAS ABLE TO PROPERLY DETECT VF AND TREATED THE PT. BELT SN (B)(4) HAS NOT BEEN RETURNED TO ZOLL. DEVICE EVAL OF BELT SN (B)(4) WAS ACCOMPLISHED THROUGH A REVIEW OF THE PT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE DEFIBRILLATION EVENT. H4 DEVICE MFG DATE: MONITOR SN (B)(4):01/2015; BELT SN (B)(4): 01/2015.

    Description of Event or Problem · 1

    A US DIST CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PT WAS TREATED WHILE AT HOME. THE DEFIBRILLATION EVENT CONSISTED OF FOUR TREATMENTS. THE FIRST TWO TREATMENTS WERE APPROPRIATELY DELIVERED WHILE THE PT WAS IN VF. THE FIRST TREATMENT WAS AT 15:09:29 (B)(6) 2015. THE POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA. THE SECOND TREATMENT WAS AT DELIVERED AT 01:35:38 ON (B)(6) 2015. THE POST-SHOCK RHYTHM WAS ASYSTOLE. THE PT WAS TREATED WHILE IN ASYSTOLE AT 01:36:03 AND 01:36:28. THE POST-SHOCK RHYTHM OF THE FOURTH TREATMENT WAS BRADYCARDIA AT 40 BPM. OVERSENSING OF THE SMALL CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTIONS OF THE THIRD AND FOURTH TREATMENTS. THE PT WAS TAKEN TO THE HOSP BY EMS. THE PT ENDED USE OF THE LIFEVEST. THE DIST ALSO RETURNED THE ASSOCIATED MONITOR SN (B)(4) AND REPORTED THAT THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327985 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| O