BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN TOUCH ZU

    MDR report key: 2442499 · Received January 31, 2012

    Report

    Report Number
    1831750-2012-00795
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 5, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DID NOT CONFIRM THE REPORTED EVENT OF THE BED EXIT NOT ALARMING WHEN A PT EXITED THE BED. THE BED EXIT WAS FOUND TO BE FUNCTIONING TO SPECIFICATION. THERE WERE NO DEFECTS OR MALFUNCTIONS FOUND WITH THE BED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT "SCOOTED OUT" THE END OF THE BED AND FELL. BED EXIT WAS REPORTEDLY ON, THOUGH IT COULD NOT BE CONFIRMED WHICH ZONE IT WAS SET TO. THE PT WAS FOUND USING THE SIDE RAIL TO PULL HIMSELF UP, AND INITIALLY DID NOT COMPLAIN OF ANY PAIN. SEVERAL HOURS LATER, LIMITATIONS IN THE ABILITY TO MOVE ONE OF HIS LEGS WAS NOTED, AND HE WAS TAKEN FOR X-RAYS WHERE A FRACTURE WAS FOUND. THE BED WAS REMOVED FOR SERVICE UNTIL AN EVALUATION COULD BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN TOUCH ZU A/C HOSPITAL BED FNL STRYKER MEDICAL 2141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR