BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1220908-2016-00030

    MDR report key: 5382585 · Received January 21, 2016

    Report

    Report Number
    1220908-2016-00030
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Report Date
    January 4, 2016
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE SUSPECT PACE/DEFIB ENGINE BOARD WAS RETURNED. THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO THE PACE/DEFIB ENGINE BOARD. THE CUSTOMER CONFIRMED THAT REPLACEMENT OF THE PACE/DEFIB ENGINE BOARD RESOLVED THE MALFUNCTION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB DISABLED" AND "PACER DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patients

    Seq Age Sex Outcome Treatment
    1