BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1981496 · Received January 11, 2011

    Report

    Report Number
    1220908-2010-03857
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT WHO WAS IN CARDIAC ARREST, THE DEVICE DISPLAYED MULTIPLE ERROR MESSAGES BUT THE COMPLAINANT DOES NOT RECALL WHAT ERROR MESSAGES WERE DISPLAYED. THE COMPLAINANT ALLEGED THAT THE MEDIC REPORTED THE DEVICE'S DISPLAY WAS MISSING ECG INFO. THE MEDIC SWITCHED THE DEVICE FROM DEFIB MODE INTO MONITOR MODE AND THE DEVICE SWITCHED BACK TO DEFIB MODE ON ITS OWN. THE MEDIC POWERED THE DEVICE OFF AND BACK ON AND THE DEVICE'S DISPLAY WAS FROZEN AND BLANK. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK