BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GPS STRETCHER

    MDR report key: 3924723 · Received June 17, 2014

    Report

    Report Number
    3006697241-2014-00515
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR OF THE BRAKE CASTERS. 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. HILL-ROM TECHNICAL SUPPORT GAVE THE ACCOUNT THE BRAKE CASTER PART NUMBERS AND THE ISSUE WILL BE RESOLVED WITH THE REPLACEMENT OF THE BRAKE CASTERS. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BRAKE WILL SET BUT WILL NOT HOLD. THE STRETCHER WAS LOCATED IN THE BED SHOP 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
    353834 GPS STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 883

    Patients

    Seq Age Sex Outcome Treatment
    1