BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD STRETCHER

    MDR report key: 3932188 · Received April 3, 2014

    Report

    Report Number
    3006697241-2014-00298
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE PEDAL SETS BUT THE WHEELS ROLL ON THE LEFT AND RIGHT HEAD BRAKE CASTERS AND THE RIGHT FOOT BRAKE CASTER. THE BRAKE PADS TURN VERY EASILY BY HAND MOST LIKELY CAUSED BY NORMAL WEAR AND TEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN APPLIED LOCITE ON THE BRAKE PADS AND THREADED ROD AND ADJUSTED ALL BRAKE CASTER PADS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE NURSE REPORTED THE BRAKES WILL SET BUT DO NOT HOLD. THE STRETCHER WAS LOCATED IN THE OFFICE AT THE FACILITY. 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
    200613 STANDARD STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8005

    Patients

    Seq Age Sex Outcome Treatment
    1