BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3931773 · Received April 15, 2014

    Report

    Report Number
    3006697241-2014-00351
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 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 LEFT SIDE RAIL WOULD NOT LATCH AND THE RATCHET RIVETS THAT SECURE THE END TUBE TO THE TOP OF THE RAIL WERE MISSING FROM THE LEFT SIDE RAIL, PREVENTING THE RAIL FROM LATCHING. THE MOST LIKELY CAUSE OF THE MISSING RATCHET RIVETS IS THAT THE SIDE RAIL WAS RAN INTO AN OBJECT SUCH AS A DOOR JAM OR WALL WHILE TRANSPORTING. 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 RATCHET RIVETS WERE REPLACED ON THE LEFT SIDE RAIL TO BY THE TECHNICIAN TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE LEFT SIDE RAIL IS MISSING THE RATCHET RIVETS AND WILL NOT LATCH. THE BED IS LOCATED IN THE BED SHOP 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
    230978 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1