BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE C-8 ASSY

    MDR report key: 6130341 · Received November 28, 2016

    Report

    Report Number
    1824206-2016-00503
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    IOQ
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE HAND PENDANT NEEDED TO BE REPLACED. PER THE HILL-ROM USER MANUAL: POWERED BED MECHANISMS CAN CAUSE SERIOUS INJURY. OPERATE THE BED ONLY WITH PERSONS CLEAR OF MOVING BED SURFACES. IF YOU ARE TRYING TO ACCESS A HYDRAULIC FUNCTION FROM THE CONTROL PANEL OR PENDANT AND THE UNIT IS NOT OPERATING PROPERLY, THE FOLLOWING MESSAGE MAY APPEAR: HEAD POSITION SENSORS NOT CALIBRATED. NOTIFY HILL-ROM THE TECHNICIAN REPLACED THE HAND PENDANT 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 THE ACCOUNT STATING THE HEAD SECTION WOULD SELF RUN WHEN THE BED IS PLUGGED IN. THE BED WAS LOCATED AT THE ACCOUNT. 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
    780821 CLINITRON RITEHITE C-8 ASSY BED, AIR FLUIDIZED IOQ HILL-ROM BATESVILLE P0800010019

    Patients

    Seq Age Sex Outcome Treatment
    1