BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS MEDICAL

    MDR report key: 1293904 · Received January 20, 2009

    Report

    Report Number
    MW5009669
    Event Type
    Injury
    Date Received
    January 20, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 20, 2009
    Manufacturer
    NIHON KOHDEN AMERICA INC
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FEMALE CAME IN FOR GALL BLADDER SURGERY -- SURGERY UNEVENTFUL, BUT WHEN PT WAS IN RECOVERY ROOM AND BEGINNING TO WAKE UP, THE O2 MONITOR READ "ATTACH PROBE" ON SCREEN INSTEAD OF READING AN O2 SAT RATE. NURSE CHANGED TO ANOTHER PROBE AND PLACED ON PT'S EAR INSTEAD OF FINGER, SAME READING APPEARED. PT BECAME UNRESPONSIVE. MD DID JAW THRUST, GAVE MORE MEDS BUT PT HAD TO INTUBATED AGAIN. O2 SAT RATE THEN SHOWN ON MONITOR SCREEN. PT UNRESPONSIVE FOR 48 HOURS, BUT WOKE UP WHILE IN ICU. PT DISCHARGED IN 2009. 1 WEEK AFTER EVENT, HOSPITALIZATION WAS LONGER THAN EXPECTED AND THE MONITOR MAY HAVE MALFUNCTION TO PREVENT REGULARLY MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS MEDICAL TELEVISON MONITOR MHX NIHON KOHDEN AMERICA INC BSM-2354A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization