BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFE-TCARE HD BED ENCLOSURE SYSTEM

    MDR report key: 970862 · Received December 28, 2007

    Report

    Report Number
    3003527644-2007-0001
    Event Type
    Death
    Date Received
    December 28, 2007
    Date of Event
    June 27, 2006
    Report Date
    August 1, 2006
    Manufacturer
    SAFE-T-CARE MANUFACTURING CO. INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SERVICE REPRESENTATIVE OF PT CARE SYSTEMS (PCS) [A MEDICAL PRODUCTS DISTRIBUTOR] DELIVERED A SAFE-TCARO BED ENCLOSURE SYSTEM TO MEDICAL CENTER ON 6/22/06. A LOW AIRLOSS MATTRESS WAS ORDERED ON FIVE DAYS LATER, APPARENTLY DUE TO REDNESS ON THE PT'S SKIN. OUR REPRESENTATIVE WAS TOLD THAT ON THE SAME DAY THE UNRESPONSIVE PT WAS FOUND BY NURSING STAFF FACE DOWN BETWEEN THE MATTRESS AND THE VINYL ENCLOSURE WALL WITH BED SIDERAILS APPARENTLY IN DOWN POSITION. APPARENTLY A CODE WAS CALLED, THE PT WAS RESUSCITATED AND SENT TO THE INTENSIVE CARE UNIT WHERE SHE EXPIRED ON THE FOLLOWING MONTH. BOTH ENCLOSURE SYSTEM AND THE LOW AIRLOSS MATTRESS WERE QUARANTINED BY THE HOSPITAL. BOTH PIECES OF EQUIPMENT HAVE NOT BEEN RETURNED TO PCS AS OF THIS DATE (APPROX A WEEK LATER). NOTIFICATION OF THE ABOVE INCIDENT WAS REPORTED TO OUR REPRESENTATIVE IN ORIGINAL MONTH AT 1:10 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-TCARE HD BED ENCLOSURE SYSTEM BED ENCLOSURE SYSTEM FNL SAFE-T-CARE MANUFACTURING CO. INC. HD

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death PLEXUS 2200 LAL MATTRESS| MANUFACTURED BY GAYMAR INDUSTIRES