BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 350016 · Received August 29, 2001

    Report

    Report Number
    1220908-2001-01146
    Event Type
    Malfunction
    Date Received
    August 29, 2001
    Report Date
    July 31, 2001
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE CLINICIAN WAS MONITORING A PT (AGE AND GENDER UNKNOWN) WHO WAS PRESENTING A VENTRICULAR TACHYCARDIA HEART RHYTHM, USING ELECTRODE WITH THE DEVICE. THE CLINICIAN THEN TURNED THE DEVICE FROM MONITOR MODE TO DEFIB MODE AND DEFIBRILLATED THE PT ONCE AT 200 JOULES, BUT THE DEVICE DISPLAYED A "CHECK PATIENT" AND A "PADDLE FAULT" ERROR MESSAGE AFTER DEPRESSING THE CHARGE BUTTON. THE CLINICIAN AGAIN ATTEMPTED TO DEFIBRILLATE THE PT AT 360 JOULES, BUT THE DEVICE DISPLAYED THE SAME ERROR MESSAGES. THE COMPLAINANT THEN OBTAINED ANOTHER DEVICE AND SUCCESSFULLY DEFIBRILLATED THE PT. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39335 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other