BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 4842096 · Received June 9, 2015

    Report

    Report Number
    1220908-2015-01411
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    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

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4) SERVICE DEPARTMENT, THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO THE SYSTEM BOARD. THE DEVICE WAS RETURNED TO THE CUSTOMER. THE SYSTEM BOARD WAS RETURNED TO ZOLL UNITED STATES. THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A FAULTY SOLDER JOINT AT THE FILTER-INDUCTOR ON THE SYSTEM BOARD. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INAPPROPRIATELY SHUT OFF WHEN ATTEMPTING TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372625 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA