BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 287687 · Received July 28, 2000

    Report

    Report Number
    1220908-2000-00729
    Event Type
    Malfunction
    Date Received
    July 28, 2000
    Date of Event
    June 30, 2000
    Report Date
    June 30, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE MEDICS WERE PACING A PT AT 70PPM (MA SETTING UNKNOWN) WHEN THEY REC'D A "POOR PAD CONTACT" ERROR MESSAGE. THE MEDICS WERE UNABLE TO CONTINUE PACING THE PT. A SECOND AMBULANCE UNIT ARRIVED ON SCENE, AND THE MEDICS CONTINUED PACING THE PT, USING THE SECOND UNIT'S DEVICE. THE PT WAS THEN TRANSPORTED TO THE HOSP. 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
    1 M SERIES DEFIBRILLATOR/PACEMAKER KRF ZOLL MEDICAL CORP. MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other