BEUDAMED
    FDA Adverse Event Other Summary report: N

    KINAIR MED-SURG

    MDR report key: 811049 · Received January 18, 2007

    Report

    Report Number
    811049
    Event Type
    Other
    Date Received
    January 18, 2007
    Date of Event
    January 14, 2007
    Report Date
    January 18, 2007
    Manufacturer
    KCI
    Product Code
    IOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALE PT ADMITTED WITH MULTIPLE PRESSURE ULCERS, OLD FRACTURE TO LUMBAR VERTEBRAE, DIABETES, END STAGE RENAL DISEASE. PT HAD LITTLE MUSCLE TONE TO CATCH HERSELF OF CONTROLLING HER MOVEMENT. PT PLACED ON A KCI KIN-AIRE BED FOR HER PRESSURE ULCERS. BED WAS BROUGHT TO FACILITY BY KCI CONTACT AND SET UP BY KCI CONTACT. BED WAS COMPLETELY INFLATED AND SIDE RAILS UP. PT FELL OUT OF BED AND FRACTURED THE RIGHT HIP. PT IS UNABLE TO TELL US HOW SHE FELL. PT WAS NOT MOBILE ENOUGH TO CLIMB OVER THE BED, OR THROUGH ANY GAP OR END OF THE BED. NURSE CARING FOR THE PT NOTES THAT WHEN THIS BED WAS INFLATED, THE SIDE RAILS ONLY EXTENDED ABOUT 6 - 8 INCHES ABOVE THE INFLATED MATTRESS. IT IS THE REPORTED CONCERN THAT THE PT, BEING OBESE TO START WITH, ROLLED OVER AND OUT OF THE BED. WHEN BED IS FULLY INFLATED, THE SIDE RAILS ONLY EXTEND 6 - 8 INCHES ABOVE THE TOP OF THE MATTRESS, INCREASING THE RISK OF A PT ROLLING OVER THEM ONTO THE FLOOR. BED WAS REPLACED BY KCI. KCI NOTIFIED OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR MED-SURG KINAIR IOQ KCI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other