BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3830219 · Received May 12, 2014

    Report

    Report Number
    3006697241-2014-00438
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE LATCH BOLT AND NUTS WERE MISSING. 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 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 SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED FROM 2007-2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH REPLACED THE LEFT SIDE RAIL LATCH NUT AND BOLT TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECH STATING THE LEFT SIDE RAIL WOULD NOT LATCH. THE BED WAS LOCATED IN ED AT THE ACCOUNT. 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
    283350 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1