BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2050518 · Received March 16, 2011

    Report

    Report Number
    1525712-2011-00101
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 29, 2009
    Report Date
    March 15, 2011
    Manufacturer
    INVACARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONSUMER STATES WHEN SHE TRIED TO REPOSITION HERSELF RESULTING IN THE MOVEMENT OF THE BED, AND SHE ALLEGEDLY ENTRAPPED HERSELF. ALTHOUGH INJURY IS ALLEGED, THE SPECIFIC INJURY AND EXTENT HAVE NOT BEEN DISCLOSED. ITS UNK IS USER INADVERTENTLY ENGAGED THEIR BED PENDANT WHILE REPOSITIONING THEMSELVES RESULTING IN THE ALLEGED INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME, SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE OR INCIDENTAL PENDANT ENGAGEMENT HAD OCCURRED. MALFUNCTION HAS NOT BEEN ESTABLISHED. BED WAS USED BY THIS CONSUMER FOR ONE YEAR WITHOUT ANY COMPLAINTS. MFR HAS NOT BEEN ABLE TO OBTAIN THE BED FOR INSPECTION AS USER REFUSES TO RELEASE THE BED. CONSUMER REPORTEDLY IS STILL USING THE BED. MDR FILED ON ALLEGED UNCONFIRMED INJURY.

    Description of Event or Problem · 1

    THE CONSUMER STATES WHEN SHE TRIED TO REPOSITION HERSELF ON THE BED, THE BED ALLEGEDLY MADE A WEIRD NOISE AND SHOT UP, SANDWICHING HER. ALTHOUGH INJURY IS ALLEGED, THE SPECIFIC INJURY AND EXTENT ARE NOT KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR