BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED EXTENDER 9153650579

    MDR report key: 4930399 · Received July 21, 2015

    Report

    Report Number
    1031452-2015-14993
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Report Date
    August 17, 2015
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    (B)(6) - INITIAL MEDWATCH REPORT, 1031452-2015-14993 SUBMITTED ON 07/21/2015 INDICATED THE WRONG MANUFACTURER AND REGISTRATION NUMBER DUE TO THE RECEIPT OF AN INCORRECT SERIAL NUMBER. THE CORRECT SERIAL NUMBER HAS BEEN OBTAINED INDICATING THE MANUFACTURER AS, (B)(4). THIS RECORD IS NOT FOR AN INVACARE MANUFACTURED PRODUCT, THEREFORE, AN OEM (ORIGINAL EQUIPMENT MANUFACTURER) NOTIFICATION WILL BE ISSUED. NO MDR REQUIRED TO BE FILED BY INVACARE.

    Description of Event or Problem · 1

    THE DEALER STATES, THE HEAD AND LEG SECTIONS ARE BINDING UP AND CAUSING THE HEAD SECTION TO DROP BACK DOWN WHEN THE CONSUMER IS TRYING TO RAISE IT.

    Description of Event or Problem · 1

    THE DEALER STATES THE HEAD AND LEG SECTIONS ARE BINDING UP AND CAUSING THE HEAD SECTION TO DROP BACK DOWN WHEN THE CONSUMER IS TRYING TO RAISE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472958 BED EXTENDER 9153650579 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL LAND AMERICA HEALTH & FITNESS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other