BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3843754 · Received February 12, 2014

    Report

    Report Number
    3006697241-2014-00139
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE SIDE RAIL IS MISSING THE SHOULDER BOLT CAUSING IT NOT TO LATCH. 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. THE TECHNICIAN REPLACED THE SIDE RAIL SHOULDER BOLT TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92924 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1