BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2012811 · Received March 1, 2011

    Report

    Report Number
    3003433498-2011-00002
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    INVACARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESIDENT REPORTEDLY CAUGHT AND LODGED THEIR ARM UNDER THE MATTRESS AND ASSIST RAIL. IN ATTEMPT TO DISLODGE THEIR ARM THEY ALLEGEDLY PARTIALLY DISLOCATED THEIR SHOULDER DUE TO THE INCIDENT, AND IS CURRENTLY WEARING A SLING. A TECHNICIAN HAS SINCE INSPECTED THE BED AND THE BED HAD NO MECHANICAL ISSUES. THE INCIDENT COULD NOT BE REPLICATED. THE RAILS WERE IN WORKING ORDER WITH NO DISCREPANCIES OBSERVED. THE USER LIKELY GRABBED THE RAIL AND SLIPPED LODGING THEIR ARM WHILE ENTERING THEIR BED. NO MALFUNCTION IS APPARENT. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. MDR FILED ON ALLEGED INJURY.

    Description of Event or Problem · 1

    THE FACILITY ALLEGES A RESIDENT GOT HIS ARM CAUGHT IN AN ASSIST RAIL AND LODGED UNDER THE MATTRESS. THE RESIDENT ALLEGEDLY SUSTAINED A PARTIALLY DISLOCATED SHOULDER AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1