BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBASSADOR 1200 PLUS BARIATRIC BED

    MDR report key: 908459 · Received August 29, 2007

    Report

    Report Number
    1651101-2007-00001
    Event Type
    Death
    Date Received
    August 29, 2007
    Date of Event
    July 22, 2007
    Report Date
    August 29, 2007
    Manufacturer
    SAFE-TCARE MANUFACTURING CO. INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE PT WAS ON THE INDICATED BARIATRIC BED, THERE WAS NO DIRECT CONNECTION OF THE BED TO THE DEATH OF THE PT. PT CARE SYSTEMS, INC. REPRESENTATIVES WERE MERELY CALLED THE DAY AFTER THE EVENT TO PICK UP THE RENTAL BED, A NORMAL TRANSACTION WITH NO INDICATION OF ANY ADVERSE EVENT.

    Description of Event or Problem · 1

    PT SUCCUMBED, APPARENTLY OF NATURAL CAUSES WHILE ON A BARIATRIC BED RENTED FROM PT CARE SYSTEMS, INC. AND MANUFACTURED BY SAFE-TCARE MANUFACTURING, INC, ACCORDING TO THE MEDWATCH REPORT SUBMITTED BY THE HOSPITAL, "THERE WAS A DELAY OF 10 MINS IN GETTING THE BED OUT OF THE DOOR DUE TO THE SIDERAILS. THE PHYSICIAN COULD NOT ACCESS THE PT'S AIRWAY TO INTUBATE BECAUSE OF THE CONTROLS AT THE TOP OF THE BED. THERE WAS A DELAY IN INTUBATION. THE PT WAS CODED AND DIED." THE PT DEATH WAS NEVER REPORTED TO ANY REPRESENTATIVE OF EITHER COMPANY. THIS INCIDENT ONLY CAME TO LIGHT BY BOTH COMPANIES AS A RESULT OF A COPY OF MEDWATCH RECEIVED BY PT CARE SYSTEMS, INC. ON AUGUST 28, 2007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death