BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 309900 · Received December 20, 2000

    Report

    Report Number
    1220908-2000-01329
    Event Type
    Malfunction
    Date Received
    December 20, 2000
    Report Date
    November 30, 2000
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING THE INCOMING INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE DISPLAYED PACER FAULTS 121, 122, 123 AND 126. THE COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other