BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2105336 · Received May 18, 2011

    Report

    Report Number
    1525712-2011-00203
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    April 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED THE BED FOLDED ON ITS OWN. MALFUNCTION UNCONFIRMED. NO HISTORY OF A PRODUCT PROBLEM. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. MDR FILED AS A CONSERVATIVE MEASURE. (B)(4).

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED THE BED FOLDED ON ITS OWN. MALFUNCTION UNCONFIRMED. NO HISTORY OF A PRODUCT PROBLEM. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. MDR FILED AS A CONSERVATIVE MEASURE.

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED THE BED FOLDED ON ITS OWN. MALFUNCTION UNCONFIRMED. NO HISTORY OF A PRODUCT PROBLEM. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. MDR FILED AS A CONSERVATIVE MEASURE.(B)(4).

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE BED FOLDED ON ITS OWN WITHOUT ANY ELECTRICAL POWER. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE BED FOLDED ON ITS OWN WITHOUT ANY ELECTRICAL POWER. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE BED FOLDED ON ITS OWN WITHOUT ANY ELECTRICAL POWER. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL LAND AMERICA HEALTH & FITNESS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other