BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE

    MDR report key: 3823390 · Received February 28, 2014

    Report

    Report Number
    1824206-2014-00673
    Event Type
    Malfunction
    Date Received
    February 28, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE PATIENT RIGHT HEAD BRAKE CASTER PAD WAS WORN AND NOT MAKING PROPER CONNECTION TO THE WHEEL TO PREVENT THE BED FROM MOVING. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE PATIENT RIGHT HEAD BRAKE CASTER 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 A HILL-ROM TECHNICIAN STATING THE PATIENT RIGHT HEAD BRAKE WAS NOT HOLDING. THE BED WAS LOCATED IN A HILL-ROM SERVICE CENTER AND NOT IN USE. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124290 CLINITRON RITEHITE BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1