BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE BED

    MDR report key: 4121845 · Received July 28, 2014

    Report

    Report Number
    1824206-2014-02035
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED AND FOUND THE BED ALARM SAID LOW PLENUM PRESSURE AND THE BED WOULD NOT STAY ON. THE TECHNICIAN CHECKED THE POWER SUPPLY AND NOTICED THE QUICK DISCONNECT TO THE FLOWER WAS BURNT. THE TECHNICIAN REPLACED THE BLOWER BOX ASSEMBLY AND THE ELECTRICAL BOX ASSEMBLY TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BED WAS ALARMING AND WHEN IT STOPPED ALARMING IT STARTED TO SMELL OF SMOKE AND STOPPED FUNCTIONING. THE BED WAS LOCATED IN (B)(6) AT THE FACILITY AND A PATIENT WAS ON THE BED AT THE TIME OF THE ALLEGATION. THE PATIENT WAS REMOVED FROM THE BED AND THE BED WAS TAKEN TO THE HILL-ROM SERVICE CENTER FOR REPAIR. 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
    439897 CLINITRON RITEHITE BED BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1