BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 264580 · Received February 17, 2000

    Report

    Report Number
    1220908-2000-00190
    Event Type
    Malfunction
    Date Received
    February 17, 2000
    Report Date
    January 18, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    KRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT ALLEGED THAT DURING A BIOMEDS ROUTINE TESTING THEY REC'D PACER FAULTS 122, 123, AND 126. THE COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT WITH THIS REPORTED INCIDENT.

    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 NA Other