BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2895817 · Received January 3, 2013

    Report

    Report Number
    1525712-2013-00067
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 4, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT # 1525712-2013-00067 INDICTING THE FDA REGISTRATION NUMBER AS 1525712 - INVACARE TAYLOR STREET. THE CORRECT FDA REGISTRATION NUMBER IS 1031452 - INVACARE (B)(4).

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REPORTING THE FOOTMOTOR. IT WAS REPORTED THAT WHEN THE USER RAISES IT THE BED DOES NOT STAY UP, AND WHEN USER LOWERS IT, IT CONTINUES TO GO DOWN AND IT WILL NOT STAY. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other