BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURAL STRETCHER

    MDR report key: 3810201 · Received February 5, 2014

    Report

    Report Number
    3006697241-2014-00107
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM TECHNICAL SUPPORT FOUND THAT THE ISSUE WAS WITH THE BRAKE/STEER LINKAGE ON THE STRETCHER. THE ACCOUNT REPRESENTATIVE DID NOT DISCLOSE WHAT WAS WRONG WITH THE LINK ARM BUT HE REPLACED IT AND THE ISSUE WAS RESOLVED AFTER THIS. PER THE HILL-ROM SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. APPLY THE BRAKE AND MAKE SURE THE STRETCHER DOES NOT MOVE. IF THERE IS MOVEMENT, LOOK AT THE BRAKE COMPONENTS FOR WEAR. APPLY THE STEER, AND MAKE SURE THE STRETCHER STEERS CORRECTLY. LOOK AT THE STEER COMPONENTS FOR WEAR. PUT THE STRETCHER IN NEUTRAL. MAKE SURE ALL FOUR CASTERS ROTATE AND ROLL FREELY. ADJUST AND REPLACE COMPONENTS IF NECESSARY. HILL-ROM TECHNICAL SUPPORT STATED THAT THIS IS A COMMON PART WHICH WEARS DOWN AS THE STRETCHER GETS OLDER AND SINCE THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED BY THE ACCOUNT, THE AGE OF THE DEVICE CANNOT BE VERIFIED AND PREVENTATIVE MAINTENANCE RECORDS CANNOT BE FOUND. THE ACCOUNT INSTALLED A BRAKE/STEER UPGRADE KIT TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BRAKES WILL SET BUT IF YOU PUSH ON THE STRETCHER THEY WILL RELEASE, BRAKES ARE NOT HOLDING. THE BED WAS LOCATED IN THE ACCOUNTS BED SHOP. THERE WAS NO PT/USER INJURY REPORTER. THIS REPORT WAS FILED I OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75813 PROCEDURAL STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8000

    Patients

    Seq Age Sex Outcome Treatment
    1