BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD STRETCHER

    MDR report key: 4003125 · Received June 26, 2014

    Report

    Report Number
    3006697241-2014-00530
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 FREELY. ADJUST OR REPLACE COMPONENTS IF NECESSARY. A SEARCH OF 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. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BRAKES ARE NOT HOLDING WHILE IN BRAKE MODE. THE STRETCHER WAS LOCATED IN A PATIENT ROOM. 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
    373180 STANDARD STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8005

    Patients

    Seq Age Sex Outcome Treatment
    1