BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT CDN, 120V, EXT

    MDR report key: 5419847 · Received February 9, 2016

    Report

    Report Number
    3006433555-2016-00041
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 13, 2016
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80436 SELECT CDN, 120V, EXT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1