BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3823341 · Received February 28, 2014

    Report

    Report Number
    3006697241-2014-00192
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE RATCHET RIVETS HOLDING THE RIGHT SIDE RAIL AND TUBE ARE BROKEN AND THE END TUBE IS BENT. PER THE HILL-ROM SERVICE MANUAL IS NECESSARY FOR STRETCHERS TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTATIVE MAINTENANCE. MAKE SURE THE SIDE RAILS ARE NOT BENT OR TWISTED. MAKE SURE THE LATCH MECHANISMS OPERATE CORRECTLY. YOU MUST HEAR AN AUDIBLE CLICK WHEN THE SIDE RAIL IS RAISED TO THE UP POSITION. CHECK FOR LOOSE OR MISSING HARDWARE. TIGHTEN, REPAIR OR REPLACE AS NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE RIGHT SIDE RAIL END TUBE, RATCHET RIVETS AND MOUNTING HARDWARE TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE RIGHT SIDE RAIL DOES NOT LATCH. THE STRETCHER IS LOCATED IN THE BED SHOP AT THE FACILITY. THERE WAS NO PT/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
    124972 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1