BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT, CDN, HI RAILS, EXT, AUX

    MDR report key: 5724468 · Received June 14, 2016

    Report

    Report Number
    3006433555-2016-00158
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Date of Event
    May 20, 2016
    Report Date
    May 20, 2016
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED WITH RESULTS OF EVALUATION, AND TO REPORT THAT THE UNIT WAS REPLACED FOR THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HI-LO ACTUATOR HOUSING HAD BROKEN AWAY FROM THE MOUNT. THOUGH NOT REPORTED, DEPENDING ON THE POSITION (HEIGHT) OF THE LIFT WHEN THE BREAKAGE OCCURRED, AN UNEXPECTED LOWERING OF THE BED COULD RESULT. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HI-LO ACTUATOR HOUSING HAD BROKEN AWAY FROM THE MOUNT. THOUGH NOT REPORTED, DEPENDING ON THE POSITION (HEIGHT) OF THE LIFT WHEN THE BREAKAGE OCCURRED, AN UNEXPECTED LOWERING OF THE BED COULD RESULT. IT WAS ALSO CONFIRMED THAT A PATIENT WAS ON THE BED WHEN THIS OCCURRED, BUT THE BED DID NOT LOWER AND THERE WAS NO INJURY TO THE PATIENT FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376676 SELECT, CDN, HI RAILS, EXT, AUX BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1