BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE BED

    MDR report key: 3841122 · Received February 26, 2014

    Report

    Report Number
    1824206-2014-00653
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKING MECHANISM ON THE BRAKE CASTER WAS WORN OUT DUE TO NORMAL WEAR AND TEAR. THE TECHNICIAN REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN FOUND THE RIGHT HEAD BRAKE WAS NOT HOLDING DURING A BETWEEN PATIENT INSPECTION. THE BED WAS LOCATED IN THE HILL-ROM SERVICE CENTER. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118590 CLINITRON RITEHITE BED BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1