BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX-OHMEDA S/5 8-MODULE FRAME

    MDR report key: 444922 · Received February 13, 2003

    Report

    Report Number
    9610105-2003-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2003
    Date of Event
    January 9, 2003
    Report Date
    February 13, 2003
    Manufacturer
    INSTRUMENTARIUM CORP, DATEX-OHMEDA DIVISION
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S NIBP DECREASED DOWN TO 70MMHG AND SPO2 DOWN TO 80% WITHOUT ANY ALARM OF THE MONITOR AND PATIENT HAD A COLLAPSE. PATIENT WAS RECOVERED AT THE ICU DEPARTMENT AND IT SEEMS THAT THE PATIENT HAS NO VISIBLE CONSEQUENCES. THE DEVICE WAS TAKEN OUT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 8-MODULE FRAME DATEX-OHMEDA 8-MODULE FRAME BSZ INSTRUMENTARIUM CORP, DATEX-OHMEDA DIVISION F-CU8-22-05 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other D-O ANESTHESIA SW LICENSE, L-ANE02.