BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE BED

    MDR report key: 3881782 · Received May 27, 2014

    Report

    Report Number
    1824206-2014-01646
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    PMA / PMN Number
    K964223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE CAUSE WAS WORN BRAKE PAD DUE TO NORMAL WEAR AND TEAR. THE TECHNICIAN REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THAT DURING A BETWEEN PT INSPECTION THAT THE BRAKES WERE NOT HOLDING WHEN APPLIED. THE BED WAS LOCATED IN THE HILL-ROM SERVICE CENTER. 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
    311561 CLINITRON RITEHITE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 08000

    Patients

    Seq Age Sex Outcome Treatment
    1