BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN TOUCH ZU

    MDR report key: 3753120 · Received April 16, 2014

    Report

    Report Number
    0001831750-2014-02912
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    November 17, 2013
    Report Date
    March 22, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO REPORT THAT WHEN A STRYKER TECHNICIAN WENT TO EVALUATE THE BED, IT HAD ALREADY BEEN PLACED BACK INTO SERVICE BY THE USER FACILITY. UPON EVALUATION, NO CASTERS WERE FOUND TO BE MISSING THE STEER AND BRAKE FUNCTIONS COULD NOT BE TESTED AS THERE WAS A PATIENT IN THE BED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CASTER CAME OFF THE BED ALLEGEDLY STARTLING THE PATIENT WHICH RESULTED IN DIFFICULTY BREATHING. SHORTLY THEREAFTER, A SECOND CASTER CAME OFF THE BED. THE HOSPITAL USED AN OVERHEAD PATIENT LIFT SYSTEM TO TRANSFER THE PATIENT SAFELY OFF THE INTOUCH BED ONTO ANOTHER BED. THE PATIENT HAD SOME ANXIETY WITH THE EVENT AND BEING SUDDENLY MOVED SO WAS GIVEN MEDICATION TO CALM THEM THROUGHOUT THE PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CASTER CAME OFF THE BED ALLEGEDLY STARTLING THE PATIENT WHICH RESULTED IN DIFFICULTY BREATHING. SHORTLY THEREAFTER, A SECOND CASTER CAME OFF THE BED. THE HOSPITAL USED AN OVERHEAD PATIENT LIFT SYSTEM TO TRANSFER THE PATIENT SAFELY OFF THE INTOUCH BED ONTO ANOTHER BED. THE PATIENT HAD SOME ANXIETY WITH THE EVENT AND BEING SUDDENLY MOVED SO WAS GIVEN MEDICATION TO CALM THEM THROUGHOUT THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232337 IN TOUCH ZU BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1