BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE

    MDR report key: 3896345 · Received May 20, 2014

    Report

    Report Number
    1824206-2014-01566
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND DURING A BETWEEN PATIENT INSPECTION OF THE BED THAT THE BRAKES WOULD NOT LOCK AND THE BED STILL ROLLED WHEN THE BRAKE WAS SET. PER THE HILL-ROM USER MANUAL, WARNING: PATIENTS MAY USE THE BED FOR SUPPORT WHILE ENTERING OR EXITING; IF THE UNIT MOVES UNEXPECTEDLY, PATIENT 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 HE LOWER END OF THE BRAKE LEVER TO LOCK THE WHEELS. TO RELEASE THE BRAKES, APPLY INWARD PRESSURE OT THE UPPER END OF THE BRAKE LEVER. THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, 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 PATIENT/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
    300706 CLINITRON RITEHITE BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1