BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBASSADOR 1200 PLUS BARIATRIC BED

    MDR report key: 952889 · Received November 7, 2007

    Report

    Report Number
    3003527644-2007-00002
    Event Type
    Injury
    Date Received
    November 7, 2007
    Date of Event
    June 10, 2007
    Report Date
    June 19, 2007
    Manufacturer
    SAFE-T-CARE MANUFACTURING, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAFE-TCARE MFG PRODUCT, THE AMBASSADOR 1200 BARIATRIC BED, WAS INSPECTED IN THE FIELD BY THE DISTRIBUTOR REP (SEE ATTACHED INCIDENT REPORT). POSSIBLE CORRECTIVE MEASURES WERE MADE AND NOTICE WAS MADE THAT THE BED OPERATED NORMALLY. UPON NOTIFICATION OF THE INCIDENT TO SAFE-TCARE MFG, THE HAND CONTROL, AND THE ELECTRIC CONTROL BOX WAS REMOVED FROM THE BED AND IMMEDIATELY SENT TO SAFET-TCARE FOR FULL INSPECTION. BOTH SUSPECT ITEMS WERE SHOWN TO BE IN GOOD WORKING CONDITION AND COMPLIED WITH ALL EXPECTATIONS. THE BED HAS BEEN PLACED IN QUARANTINE AT THE PT CARE SYSTEMS, INC. WAREHOUSE UNTIL FURTHER NOTICE.

    Description of Event or Problem · 1

    ACCORDING TO MEDWATCH REPORT, THIS EVENT OCCURRED AT A SELECT MED CTR FACILITY. ALLEGEDLY, AN AMBASSADOR 1200 BARIATRIC BED MFG BY SAFE-TCARE MFG, INC. WAS INVOLVED IN AN INCIDENT IN WHICH THE ABOVE PT WAS ELEVATED, WITHOUT PT OR HOSP PERSONNEL PROVOCATION. THE PT ALLEGEDLY GRABBED A HOSP CNA (EMPLOYEE) WHO WAS BEDSIDE AND LIFTED HER UPWARD UNTIL A LIGHTING FIXTURE ON THE CEILING WAS BROKEN BY A FIXTURE ON THE BED. DURING THE EVENT, THE CNA RECEIVED A BROKEN ARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other ULTRACAIR LOW AIRLOSS MATTRESS REPLACEMENT OWNED| AND RENTED TO HOSP BY PT CARE SYSTEMS, INC.