BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 5410977 · Received February 4, 2016

    Report

    Report Number
    1220908-2016-00254
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Report Date
    January 18, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE. THE CUSTOMER HAS RESPONDED AND INDICATED THAT THE DEVICE HAS BEEN REPAIRED (BRIDGE BOARD WAS REPLACED) AND RETURNED TO SERVICE. THE DEVICE WILL NOT BE RETURNING TO ZOLL.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2016-00195, 1220908-2016-00246 THROUGH 1220908-2016-00253, 1220908-2016-00255 THROUGH 1220908-2016-00257 AND 1220908-2016-00259 THROUGH 1220908-2016-00265 FOR SIMILAR EVENTS RECEIVED FROM OUR DISTRIBUTOR IN A BATCH FOR ITEMS FOUND OVER A LONG PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68534 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1