BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 4875285 · Received June 23, 2015

    Report

    Report Number
    1220908-2015-01537
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4) SERVICE DEPARTMENT, THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO THE LITHIUM BATTERY ON THE SYSTEM BOARD. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ZOLL MEDICAL CORP. RECOMMENDS REPLACEMENT OF THE LITHIUM BATTERY ON THE SYSTEM BOARD EVERY 5 YEARS. THIS DEVICE IS APPROXIMATELY 9 YEARS OLD FROM DATE OF MANUFACTURE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404598 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORP E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA