BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3078933 · Received April 25, 2013

    Report

    Report Number
    1031452-2013-00792
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Report Date
    April 1, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR. REPORT # 1031452-2013-00792 INDICATING THE MANUFACTURER AS CARROLL HEALTHCARE WHEN THE ACTUAL MANUFACTURER IS INVACARE (B)(4).

    Description of Event or Problem · 1

    PER PROVIDER HEAD SECTION OF THE BED IS ALLEGEDLY DROPPING. PATIENT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178034 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other