BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142609 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00271
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    March 2, 2011
    Report Date
    June 21, 2011
    Manufacturer
    INVACARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED THAT MAY HAVE A POTENTIAL FOR SERIOUS INJURY. ALLEGEDLY, THE (B)(6) LB CONSUMER WAS ON THE BED WHEN IT DROPPED 1.5 FEET TO THE LOWEST POSITION. IT IS UNK IF THE CONSUMER WAS LAYING, SITTING, STANDING OR JUMPING ON THE BED AT THE TIME. THE CONSUMER ALLEGES THEY DID NOT USE THE CONTROL PANEL TO MAKE A HEIGHT ADJUSTMENT AT THE TIME OF THE ALLEGED INCIDENT. THIS BED HAS BEEN TAKEN OUT OF SERVICE. MAINTENANCE HISTORY AND PREVIOUS PRODUCT ISSUES PRIOR TO THIS ALLEGED INCIDENT ARE UNK. PRODUCT HAS NOT BEEN RETURNED FOR AN EVAL SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE BED FRAME ALLEGEDLY DROPPED FROM 1.5 FEET TO THE LOWEST POSITION WITHOUT PRESSING ANY BUTTONS ON THE BED PENDANT. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FNL INVACARE HSCS7

    Patients

    Seq Age Sex Outcome Treatment
    1