BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3884006 · Received February 14, 2014

    Report

    Report Number
    3006697241-2014-00145
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON, INVESTIGATION, THE TECHNICIAN FOUND THAT THE BRAKE CASTERS ON THE DEVICE WERE OUT OF ADJUSTMENT. HE DOES NOT KNOW WHAT EXACTLY CAUSED THIS, BUT HE THINKS THE MOST LIKELY CAUSE IS DUE TO REGULAR USE. THE TECHNICAL SPECIFICATION OF THIS PART STATES THAT THE BRAKE CASTERS DO NOT NEED TO BE ADJUSTED OR CHANGED FOR 10,000 REPETITIONS AND SINCE THE DEVICE HAS BEEN IN SERVICE SINCE 2008 AND IS USED REGULARLY, IT HAS PROBABLY GONE WAY 10,000 REPETITIONS THRESHOLD. 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 ADJUSTED 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 BRAKES ARE NOT HOLDING. THE BED IS LOCATED IN THE ER OF 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
    98102 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1