BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 4232621 · Received September 11, 2014

    Report

    Report Number
    3006697241-2014-00663
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND ALL FOUR BRAKES CASTERS STEMS WERE WORN OUT. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED ALL FOUR BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES ARE NOT HOLDING WHEN ENGAGED. THE BED WAS LOCATED AT THE ACCOUNT IN THE SURGERY DEPARTMENT. 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
    563081 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1