BEUDAMED
    FDA Adverse Event Death Summary report: N

    S/5 CCM CRITICAL CARE MONITOR

    MDR report key: 300709 · Received October 13, 2000

    Report

    Report Number
    9610105-2000-00005
    Event Type
    Death
    Date Received
    October 13, 2000
    Date of Event
    September 14, 2000
    Report Date
    September 18, 2000
    Manufacturer
    INSTRUMENTARIUM CORP / DATEX-OHMEDA DIVISION
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DOCTORS CLAIMED THAT WERE MISLED BY THE "PACE MAKER SYNCH. MARKER" WHICH SEEMED LIKE AN "R" COMPLEX ON A PT'S WAVEFORM THAT HAD VF WITH PACING. DURING ABOVE SITUATION THE MONITOR GAVE HR READINGS AND DID NOT ALARM FOR VENTRICULAR FIBRILLATION OR ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 CCM CRITICAL CARE MONITOR MULTIPARAMETER CRITICAL CARE MONITOR DSI INSTRUMENTARIUM CORP / DATEX-OHMEDA DIVISION S-00C02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death