BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBASSADOR 1200

    MDR report key: 903490 · Received July 31, 2007

    Report

    Report Number
    903490
    Event Type
    Death
    Date Received
    July 31, 2007
    Date of Event
    July 22, 2007
    Report Date
    July 31, 2007
    Manufacturer
    SAFE-T CARE MANUFACTURING, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HYPOTENSIVE. THERE WAS A DELAY OF 10 MINUTES IN GETTING THE BED OUT OF THE DOOR DUE TO THE SIDERAILS. THE PHYSICIAN COULD NOT ACCESS THE PATIENT'S AIRWAY TO INTUBATE BECAUSE OF THE CONTROLS AT THE TOP OF THE BED. THERE WAS A DELAY IN INTUBATION. THE PATIENT WAS CODED AND DIED. IT WOULD BE HELPFUL IF THE STEERING CONTROLS AT THE TOP OF THE BED COULD BE REMOVED WHEN NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBASSADOR 1200 BED, BARIATRIC FNL SAFE-T CARE MANUFACTURING, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death CARDIAC DRUGS