BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GPS STRETCHER

    MDR report key: 3810203 · Received February 5, 2014

    Report

    Report Number
    3006697241-2014-00109
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 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 TECHNICIAN FOUND THE BRAKE CASTER SWIVEL MECHANISMS ARE WORN. PER THE HILL-ROM SERVICE MANUAL ANNUAL PREVENTATIVE MAINTENANCE MUST BE PERFORMED TO INSURE ALL BED FEATURES ARE FUNCTIONING AS ORIGINALLY DESIGNED. PARTICULAR ATTENTION MUST BE ADDRESSED ON SAFETY FEATURES INCLUDING BUT NOT LIMITED TO: CASTER BRAKING SYSTEMS. A SEARCH OF HILL-ROM MAINTENANCE RECORDS DID SHOW THAT PREVENTATIVE MAINTENANCE HAS BEEN PERFORMED ANNUALLY. THE TECHNICIAN REPLACED ALL BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TECHNICIAN REPORTED THAT WHILE PERFORMING PREVENTATIVE MAINTENANCE ON THE STRETCHER HE FOUND THAT ALL BRAKE CASTERS SWIVEL WHILE IN BRAKE MODE. THE TECHNICIAN FOUND THE STRETCHER IN THE ER HALLWAY. 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
    75978 GPS STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 881

    Patients

    Seq Age Sex Outcome Treatment
    1