BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE BED

    MDR report key: 3931571 · Received April 14, 2014

    Report

    Report Number
    1824206-2014-01166
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND DURING A BETWEEN PT INSPECTION OF THE BED THAT THE FOOT BRAKE WOULD NOT HOLD DUE TO A WORN BRAKE PAD. THE TECH REPLACED THE 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 TECH STATING THE FOOT BRAKE CASTER NOT LOCKING (BRAKES NOT HOLDING). THE BED WAS LOCATED IN A HILL-ROM SVC CTR 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
    226802 CLINITRON RITEHITE BED BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1