BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR STRETCHER

    MDR report key: 3883983 · Received February 14, 2014

    Report

    Report Number
    3006697241-2014-00146
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, TECHNICIAN FOUND THE RIGHT FOOT AND LEFT HEAD BRAKE CASTERS ON THE DEVICE WERE DEFECTIVE. HE REPORTED THAT THE CASTERS ON THE DEVICE HAVE BEEN IN SERVICE SINCE 1997 WITH THESE BEING THE ORIGINAL CASTERS ON THE DEVICE AS THERE IS NO RECORD PART REPLACEMENT. HE ASSOCIATES THIS FAILURE TO REGULAR WEAR AND TEAR DUE TO THE AGE OF THE DEVICE. THERE IS NO RECORD OF A PM BEING DONE BY HILL-ROM AT THE ACCOUNT AND HE SAYS IF THEY HAD A PM HE MIGHT HAVE BEEN ABLE TO DETECT THAT THE CASTERS WERE WEARING OUT AND REPLACED THEM BEFORE THE ACTUAL FAILURE. 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 TECHNICIAN REPLACED THE RIGHT FOOT AND LEFT HEAD BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BRAKES WOULD SET BUT NOT HOLD. THE BED IS LOCATED IN THE ENGINEERING DEPARTMENT OF THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98401 TRANSTAR STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1