BEUDAMED
    FDA Adverse Event Death Summary report: N

    3900P PULSE OXIMETER

    MDR report key: 1409063 · Received June 29, 2009

    Report

    Report Number
    9613557-2009-00003
    Event Type
    Death
    Date Received
    June 29, 2009
    Date of Event
    May 14, 2009
    Report Date
    June 29, 2009
    Manufacturer
    GE HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    983684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE PERFORMED A CHECKOUT OF THE UNIT AND FOUND IT TO OPERATE WITHIN MFR'S SPECIFICATIONS. SIMULATOR TESTING WAS ALSO PERFORMED, AND THE UNIT OPERATED AS EXPECTED. IT SHOULD BE NOTED THAT GE HEALTHCARE WAS ONLY PROVIDED THE MONITOR AND CABLE FOR TESTING. THE PROBE USED ON THE PT COULD NOT BE LOCATED BY THE HOME HEALTHCARE AGENCY OR THE FAMILY.

    Description of Event or Problem · 1

    PER REPORT FROM DISTRIBUTOR, PT WAS BEING MONITORED BY THE PULSE OXIMETER IN A HOMECARE SETTING. UPON ARRIVAL AT THE HOSP, THE PULSE OXIMETER REPORTEDLY INDICATED AN OXYGEN SATURATION LEVEL LOWER THAN WHAT THE MONITOR INDICATED IN THE PT'S HOME. IT WAS REPORTED THAT THE PT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3900P PULSE OXIMETER PULSE OXIMETER DQA GE HEALTHCARE 3900P

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Death