BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS BED 9153650455

    MDR report key: 5134550 · Received October 8, 2015

    Report

    Report Number
    1031452-2015-16196
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Report Date
    September 22, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: BEDS, MATTRESSES, RAILS. JUNCTION BOX, NOT ABLE TO DUPLICATE ISSUE. NOT SET UP TO TEST UNDERLOAD. COMPLAINT OF "BED HEAD SECTION GOES HALF WAY UP, BUT THEN DROPS DOWN" WAS NOT CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    DEALER IS STATING THAT THE BED HEAD SECTION GOES HALF WAY UP, BUT THEN DROPS DOWN.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: BEDS, MATTRESSES, RAILS. JUNCTION BOX, NOT ABLE TO DUPLICATE ISSUE. NOT SET UP TO TEST UNDERLOAD. COMPLAINT OF "BED HEAD SECTION GOES HALF WAY UP, BUT THEN DROPS DOWN" WAS NOT CONFIRMED. DEALER IS STATING THAT THE BED HEAD SECTION GOES HALF WAY UP, BUT THEN DROPS DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669818 CS BED 9153650455 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE FLORIDA OPERATIONS VC5310

    Patients

    Seq Age Sex Outcome Treatment
    1