BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SC 9000

    MDR report key: 218917 · Received April 9, 1999

    Report

    Report Number
    1220063-1999-00011
    Event Type
    Malfunction
    Date Received
    April 9, 1999
    Date of Event
    March 12, 1999
    Report Date
    April 9, 1999
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. EM-P
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT'S HEART RATE ROSE TO OVER 200 (206-214). DEFIBRILLATION WAS RELEASED, AFTER THAT THE MONITOR WENT BLANK AND OFFLINE. AFTER APPROX 3 MINUTES, THE MONITOR WAS ON AGAIN. VALUES OVER 200 ARE MISSING ON THE TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC 9000 PATIENT MONITOR KMI SIEMENS MEDICAL SYSTEMS, INC. EM-P 4316928 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other