BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE BED

    MDR report key: 3810393 · Received April 11, 2014

    Report

    Report Number
    1824206-2014-01162
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND DURING A BETWEEN PT INSPECTION OF THE BED THAT THE RIGHT HEAD BRAKE WOULD NOT HOLD THE BED IN PLACE WHEN THE BRAKE WAS SET. PER THE HILL-ROM USER MANUAL, WARNING: PTS MAY USE THE BED FOR SUPPORT WHILE ENTERING OR EXITING; IT THE UNIT MOVES UNEXPECTEDLY, PT INJURY COULD OCCUR. WHEN THE UNIT IS UNATTENDED, ENSURE THAT BOTH BRAKES ARE LOCKED. THE BRAKES FOR THE CLINITRON BED ARE LOCATED AT THE RIGHT, HEAD END AND THE LEFT, FOOT END OF THE UNIT. TO APPLY THE BRAKES, STEP ON THE LOWER END OF THE BRAKE LEVER TO LOCK THE WHEELS. TO RELEASE THE BRAKES, APPLY INWARD PRESSURE TO THE UPPER END OF THE BRAKE LEVER. THE TECHNICIAN REPLACED THE RIGHT HEAD BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN A HILL-ROM SERVICE CENTER AND NOT IN USE. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221685 CLINITRON RITEHITE BED BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1