BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBASSADOR 1200 PLUS

    MDR report key: 1410696 · Received February 24, 2009

    Report

    Report Number
    1410696
    Event Type
    Death
    Date Received
    February 24, 2009
    Date of Event
    September 22, 2008
    Report Date
    February 18, 2009
    Manufacturer
    SAFE-TCARE MANUFACTURING, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO HARBORVIEW MED CTR FOR AN ELECTIVE PARATHYROID RESECTION. PT'S CONDITION AND PRE-EXISTING PRESSURE ULCERS REQUIRED THAT SHE USE AN AMBASSADOR 1200 PLUS BED FRAME WITH A MATTRESS OVERLAY. PT FOUND OUT OF BED ON FLOOR WITH NO PULSE AND NOT BREATHING. SEE SCANED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBASSADOR 1200 PLUS BARIATRIC BED FNL SAFE-TCARE MANUFACTURING, INC. AMB1200

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death