BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEBRIBRILLATOR

    MDR report key: 3458158 · Received September 27, 2013

    Report

    Report Number
    1220908-2013-02592
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Report Date
    September 10, 2013
    Manufacturer
    ZOLL MED CTR
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT 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 DISPLAY FLICKERED AND CRITICAL INFORMATION COULD NOT BE READ. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490392 R SERIES DEBRIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MED CTR R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA