BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3071979 · Received April 22, 2013

    Report

    Report Number
    1031452-2013-00767
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR. REPORT # 1031452-2013-00767 INDICTING THE JUNCTION BOX IS BROKEN. THIS IS A NON REPORTABLE EVENT. THE SC900DLX LOW BED HAS A BATTERY BACK UP AND IS ALSO EQUIPPED WITH A HAND CRANK TO OPERATE THE BED FUNCTIONS.

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE (B)(4) ELECTRIC BED CONTROL BOX WAS INOPERABLE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172357 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS SC900-80WDLX-QSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other