BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 292009 · Received August 18, 2000

    Report

    Report Number
    1220908-2000-00840
    Event Type
    Malfunction
    Date Received
    August 18, 2000
    Report Date
    July 21, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A PT (AGE AND GENDER UNKNOWN), THE DEVICE GOT AN ALARM AFTER 15-20 SECONDS. THE MEDIC CHECKED THE CABLES AND PADS, AND DETERMINED THEY WERE "FINE". THE MEDIC THEN SUSPENDED THE ALARM, AT WHICH TIME TI CAME BACK ON AGAIN AND THE DEVICE WAS UNABLE TO PACE. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER KRF ZOLL MEDICAL CORP. MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other