BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE BED

    MDR report key: 3850821 · Received March 21, 2014

    Report

    Report Number
    1824206-2014-00939
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE CASTER NOT HOLDING DUE TO NORMAL WEAR AND TEAR. PER THE HILL-ROM USER MANUAL, WARNING: PATIENTS MAY USE THE BED FOR SUPPORT WHILE ENTERING AND 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 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. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE 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 BRAKE CASTERS WERE NO ENGAGING (BRAKE IS NOT HOLDING). THE BED WAS LOCATED IN A HILL-ROM SERVICE CENTER AND NOT IN USE. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169506 CLINITRON RITEHITE BED BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1