BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3830153 · Received May 8, 2014

    Report

    Report Number
    3006697241-2014-00430
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE RATCHET RIVETS THAT SECURE THE END TUBE TO THE TOP OF THE RAIL WERE MISSING FROM THE SIDE RAIL, PREVENTING THE RAIL FROM LATCHING. THE MOST LIKELY CAUSE OF THE MISSING RATCHET RIVETS FORCE SUCH AS THE STRETCHER BEING RAN INTO AN OBJECT DURING TRANSPORT. PER THE HILL-ROM SERVICE MANUAL IT 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 AND 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 SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2006 THROUGH 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE RATCHET RIVETS WERE REPLACED IN THE RIGHT SIDE RAIL BY THE TECHNICIAN TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THE RIGHT SIDE RAIL WOULD NOT LATCH. THE STRETCHER IS LOCATED ON THE 1ST FLOOR 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
    278196 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1