BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED 3

    MDR report key: 2222910 · Received July 15, 2011

    Report

    Report Number
    1824206-2011-03754
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN INSPECTED THE BED AND FOUND THAT 3 LIFT ARM STRAP BOLTS WERE MISSING FROM THE LIFT ARM PIVOT BLOCK/STRAP AREA. THE REMAINING BOLT WAS LOOSE AND HANGING. THIS CONDITION ALLOWED THE BED TO TILT. TECHNICIAN INFORMED THE ACCOUNT THAT THESE BOLTS ARE TO BE INSPECTED EVERY 6 MONTHS PER THE SERVICE MANUAL (B)(4), "INSPECTING THE PIVOT POINT FASTENERS". WHEN TECHNICIAN ASKED ABOUT THE PM SCHEDULE OF THE BED, THE CUSTOMER REFUSED TO ANSWER ANY FURTHER QUESTIONS. THE CUSTOMER WILL REPAIR THE BED. REPAIR HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT THEY WERE PUSHING AN AFFINITY BED WITH A PT ON THE BED TO THE C SECTION ROOM FOR A BABY DELIVERY AND THE FRAME OF THE AFFINITY BED COLLAPSED, THROWING THE PT OUT OF THE BED. (B)(6) ALLEGED THAT PT WAS SHAKEN UP. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED 3 BIRTHING BED HDD HILL-ROM INC. P3700

    Patients

    Seq Age Sex Outcome Treatment
    1