BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS7 BED

    MDR report key: 10461298 · Received August 27, 2020

    Report

    Report Number
    1525712-2020-00020
    Event Type
    Injury
    Date Received
    August 27, 2020
    Report Date
    August 10, 2020
    Manufacturer
    INVACARE CORPORATION
    Product Code
    LLI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROVIDER ADVISED THAT THE BED IS INSPECTED PRIOR TO USE BY EACH NEW PATIENT. HE STATED THAT THEY DIDN'T NOTICE THAT THE END PLUG WAS MISSING UNTIL AFTER THE INJURY OCCURRED. THE PROVIDER IS NOT RETURNING THE RAIL TO INVACARE. HE ADVISED THAT THERE IS NOTHING WRONG WITH THE RAIL; THE CAP JUST FELL OUT. HE STATED THAT THEY ARE ORDERING REPLACEMENT CAPS FOR THE RAIL TO CORRECT THE ISSUE. THE UNDERLYING CAUSE OF THE CAP FALLING OUT OF THE RAIL IS UNDETERMINED. THIS FAILURE MODE WAS PREVIOUSLY INVESTIGATED, AND AS A PREVENTATIVE ACTION, THE FOLLOWING STATEMENT WAS ADDED TO THE ASSIST RAIL INSTALLATION USER MANUAL: "TO AVOID DEATH, INJURY OR DAMAGE DUE TO IMPROPER MAINTENANCE OR INSPECTION. ALWAYS MAINTAIN AND INSPECT EQUIPMENT PER THE INSTRUCTIONS IN THIS MANUAL. CONTACT A QUALIFIED TECHNICIAN OR INVACARE IF ANY OF THE FOLLOWING ISSUES ARE PRESENT: LOOSE OR MISSING PARTS SUCH AS END CAPS, KNOBS, BOLTS, SCREWS ETC., SHOULD BE SECURED OR REPLACED. SHARP EDGES OR SURFACES SHOULD BE CORRECTED OR REPLACED." A DESIGN CHANGE HAS SINCE BEEN MADE TO THESE ASSIST RAILS. THE PLASTIC END CAP WAS REPLACED WITH A PERMANENT STEEL COVER, WHICH IS BRAZED ONTO THE TUBE ENDS AND BUFFED TO CREATE A SMOOTH EDGE.

    Description of Event or Problem · 1

    A PROVIDER REPORTED THAT AN END PLUG FELL OUT OF THE ASSIST RAIL ON A CS7 BED, AND THE PATIENT CUT THEIR LEG ON THE RAIL AND REQUIRED 3 OR 4 STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927690 CS7 BED BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE LLI INVACARE CORPORATION IHCS7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other