BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 7694152 · Received July 17, 2018

    Report

    Report Number
    1220908-2018-01978
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 25, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946009175
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A FAULTY BATTERY. THE BATTERY WOULD NOT CHARGE AND INDICATED ERRORS CONSISTENT WITH THE BATTERY CURRENT BELOW THE SPECIFIED RANGE. THE BATTERY WAS REPLACED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER DURING THE INVESTIGATION INDICATED THAT THIS DEVICE IS KEPT ON THE AMBULANCE PLUGGED INTO THE AUXILIARY POWER WITH THE BATTERY REMAINING IN THE DEVICE WHILE IT IS NOT IN USE. ZOLL SUGGESTS THAT CUSTOMER'S HAVE A SUFFICIENT NUMBER OF BATTERY PACKS AND CHARGERS TO ENSURE ADEQUATE SUPPLY OF FULLY CHARGED PRIMARY AND SPARE USE BATTERY'S. IT IS ALSO SUGGESTED THAT BATTERIES BE ROTATED TO A SCHEDULE BASED ON USAGE AND PERIODIC DEEP CYCLING. THE BATTERY INVOLVED IN THE REPORTED EVENT WAS MANUFACTURED AT THE END OF 2015 AND DETERMINED TO BE APPROXIMATELY 36 MONTHS OLD. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD FEMALE PATIENT, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535917 E SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION E SERIES NA 00847946009175

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR