BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3891668 · Received February 4, 2014

    Report

    Report Number
    3006697241-2014-00105
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE CASTERS ARE WORN AND THE BRAKE CASTERS WOULD ROTATE IN A CIRCLE IF THE STRETCHER WAS PUSHED ON THE SIDE WHILE IN BRAKE MODE. THE DEVICE REFERENCED IN THIS REPORT IS OVER 12 MONTHS OLD AND ACCORDING THE RECOMMENDED PREVENTATIVE MAINTENANCE SCHEDULE AT LEAST ONE PM SHOULD BE PERFORMED EVERY 12 MONTHS. THEREFORE THE ACCEPTANCE CRITERIA, BASED ON THE DHR, WERE DETERMINED TO BE ACCEPTABLE AT THE TIME THE DEVICE WAS RELEASED. GIVEN THE TIME WHICH HAS ELAPSED, THE ALLEGED FAILURE OF THE DEVICE WOULD NOT BE RELATED TO ANY ISSUE WHICH OCCURRED DURING THE MANUFACTURING PROCESS. THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BRAKE CASTERS WOULD ROTATE IN A CIRCLE WHILE IN BRAKE MODE. 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
    73685 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8040

    Patients

    Seq Age Sex Outcome Treatment
    1