BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURAL STRETCHER

    MDR report key: 3883830 · Received February 13, 2014

    Report

    Report Number
    1824206-2014-00416
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRETCHER WAS EVALUATED BY THE HILL-ROM THE BRAKE PAD WAS REPLACED AND ADJUSTED. NO FURTHER TECHNICIAN. THE TECHNICIAN FOUND THAT THE LEFT HEAD CASTER BRAKE PAD WAS NOT HOLDING FIRMLY. THE BRAKE PAD ON THIS CASTER WAS OUT OF ADJUSTMENT DUE TO WORN THREADS IN ITS BORE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS STRETCHER. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE BRAKE PAD WAS REPLACED AND ADJUSTED. 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 BRAKES WERE NOT HOLDING. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96730 PROCEDURAL STRETCHER PROCEDURAL STRETCHER FPO HILL-ROM, INC. P8000G000980

    Patients

    Seq Age Sex Outcome Treatment
    1