BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIR

    MDR report key: 1657413 · Received April 8, 2010

    Report

    Report Number
    1625774-2010-00026
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BED WAS TESTED PER QUALITY CONTROL PROCEDURES INCLUDING TESTING OF SIDE RAIL LOCKING MECHANISMS AND MET SPECIFICATIONS ON (B)(6) 2010, PRIOR TO PLACEMENT WITH THE PT ON (B)(4) 2010. THERE WERE NO PROBLEMS REPORTED PRIOR TO THE ALLEGED EVENT ON (B)(4) 2010. THE BED WAS RETURNED TO THE KCI SERVICE CENTER FOR EVALUATION. EVALUATION OF THE BED CONCLUDED THAT THE BED DID NOT MEET SPECIFICATIONS; THE SIDE RAIL ARM WELDMENT ASSEMBLY WAS SEPARATED (BENT) PREVENTING THE SIDE RAIL FROM LOCKING IN THE FULL UPRIGHT POSITION. IT CANNOT BE DETERMINED WHEN THE DAMAGE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BECOME RESTLESS AND WAS MOVING BACK AND FORTH ON THE BED AND WHEN HE TURNED TO HIS RIGHT SIDE, THE SIDE RAIL GAVE WAY AND THE PT FELL TO THE FLOOR. THE FACILITY DID NOT INDICATE WHICH SIDE RAIL ALLEGEDLY FELL. THE NURSE (RN) SUPV STATED IT WAS UNCLEAR IF THE PT MAY HAVE BEEN ABLE TO UNLOCK THE SIDE RAIL OR THE STAFF MAY HAVE LEFT IT DOWN. THE PT WAS SENT FOR A CT SCAN. THE RESULTS FOR THE CT SCAN WERE NEGATIVE FOR INJURY RELATED TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR IOQ KCI USA, INC. MEDSURG NA

    Patients

    Seq Age Sex Outcome Treatment
    1