BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE BED

    MDR report key: 3931572 · Received April 14, 2014

    Report

    Report Number
    1824206-2014-01165
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 15, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE HAND CONTROL WAS INOPERATIVE CAUSING THE HEAD SECTION TO GO UP AND DOWN BY ITSELF DUE TO PINCHED WIRE IN THE HAND PENDANT CABLE CAUSED BY BEING WRAPPED AROUND THE CASTER. THE TECH REPLACED THE HAND PENDANT TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE BED WOULD GO UP AND DOWN BY ITSELF. THE BED WAS LOCATED AT THE FACILITY. 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
    226783 CLINITRON RITEHITE BED BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1