BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 599426 · Received June 23, 2004

    Report

    Report Number
    1220908-2004-01295
    Event Type
    Malfunction
    Date Received
    June 23, 2004
    Report Date
    June 2, 2004
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO MONITOR A PATIENT. THE DEVICE DISPLAYED "CALIBRATION REQ" AND "USER SETUP REQUIRED" MESSAGES. CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other