BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFE-TCARE BED ENCLOSURE SYSTEM

    MDR report key: 3127094 · Received August 2, 2006

    Report

    Report Number
    1651101-2006-00001
    Event Type
    Injury
    Date Received
    August 2, 2006
    Date of Event
    June 27, 2006
    Report Date
    August 1, 2006
    Manufacturer
    SAFE-T-CARE MANUFACTURING, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SAFE-TCARE MFG DISTRIBUTOR -STC- (B)(6) - DELIVERED A SAFE-TCARE HD BED ENCLOSURE SYSTEM FOR USE WITH A PT AT (B)(6). AT A LATER DATE AN AIR MATTRESS WAS REQUESTED BY (B)(6) AND PCS DELIVERED AND INSTALLED IT. PCS RECEIVED NO COMMUNICATION OF EQUIPMENT PROBLEMS OR MALFUNCTIONS DURING THE PERIOD THE ENCLOSURE SYSTEM AND AIR MATTRESS WAS IN THE FACILITY. STC RECEIVED A PHONE CALL FROM A DISTRIBUTOR REP SAYING THAT A PT HAD BEEN FOUND UNRESPONSIVE IN THE ENCLOSURE AND THAT THE UNIT(S) HAD BEEN QUARANTINED AT THE FACILITY. THE UNIT WAS CHECKED BY THE DISTRIBUTOR REP AND NO PROBLEMS WERE FOUND WITH UNIT(S). THE FIRST CORRESPONDENCE STC RECEIVED FROM THE FACILITY WAS IN THE FAXED FROM OF MED WATCH WITH THE INFO OF PT EXPIRATION ON (B)(6) 2006.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death