BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3330282 · Received September 6, 2013

    Report

    Report Number
    1031452-2013-01850
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Report Date
    August 27, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1031452-2013-01850 INDICTING THE BRAND NAME AS A POWERED PATIENT ROTATION BED WHEN IN FACT IT IS AN AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS.

    Description of Event or Problem · 1

    DEALER STATES HI LOW CRANK IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444586 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other