BEUDAMED
    FDA Adverse Event Summary report: N

    KINAIR

    MDR report key: 1350166 · Received March 11, 2009

    Report

    Report Number
    1625774-2009-00024
    Date Received
    March 11, 2009
    Date of Event
    February 7, 2009
    Report Date
    February 7, 2009
    Manufacturer
    KCI USA, INC.
    Product Code
    INX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE USER FACILITY, THE SIDE RAILS OF THE KINAIR MEDSURG WERE FULLY RAISED. THE USER FACILITY ALSO REPORTED THAT THE HEAD OF THE BED WAS ARTICULATED TO APPROX 10 -20 DEGREES. THE USER FACILITY REPORT ALSO CONFIRMED THAT THE PT DID NOT SUSTAIN AN INJURY. KINAIR MEDSURG LABELING CAUTIONS "WHETHER AND HOW TO USE SIDE RAILS OR OTHER RESTRAINTS ARE DECISIONS THAT SHOULD BE BASED ON EACH PT'S INDIVIDUAL NEEDS AND SHOULD BE MADE BY THE PT AND THE PT'S FAMILY, PHYSICIAN AND CAREGIVERS, WITH FACILITY PROTOCOLS IN MIND. CONSIDER NOT ONLY THE CLINICAL AND OTHER NEEDS OF THE PT BUT ALSO THE RISKS OF DEATH OR SERIOUS INJURY FROM FALLING OUT OF BED AND FROM PT ENTRAPMENT IN OR AROUND THE SIDE RAILS, RESTRAINTS OR OTHER ACCESSORIES" AND TO "MONITOR RESTRAINED PTS FREQUENTLY TO GUARD AGAINST PT ENTRAPMENT AND MIGRATION." THE KINAIR MEDSURG IS A POWERED FLOTATION THERAPY BED (PRODUCT CODE IOQ), AND, THEREFORE, IT IS EXEMPT FROM THE GUIDANCE FOR INDUSTRY AND FDA STAFF: HOSP BED SYSTEM DIMENSIONAL AND ASSESSMENT GUIDANCE TO RECUCE ENTRAPMENT, EXCEPT FOR THOSE SPACES WITHIN THE PARAMETER OF THE SIDE RAIL (ZONE 1), IN WHICH THE KINAIR MEDSURG DOES PASS. ALTHOUGH THERE WAS NO REPORTED DEVICE MALFUNCTION, THE UNIT WAS RETURNED TO THE KCI SERVICE CENTER AND TESTED PER QC PROCEDURES. THE UNIT MET SPECS. IN ADDITION, THE KINAIR MEDSURG WAS TESTED PER QC PROCEDURES AND MET SPECS BEFORE IT WAS PLACED WITH THE PT IN 2008. KCI IS FILING THIS MDR AS A RESULT OF THE PREVIOUS MDR FILED BY THE REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WITH A SMALL STATURE AND AN ABNORMAL MENTAL STATUS ALLEGEDLY BECAME ENTRAPPED BETWEEN THE SIDE RAIL AND THE MATTRESS OF THE KINAIR MEDSURG. THERE WAS NO REPORT OF A SERIOUS INJURY NOR WAS THERE A REPORT OF A PRODUCT MALFUNCTION. THIS INFO WAS ALSO PROVIDED BY THE USER FACILITY THROUGH THE MEDWATCH PROGRAM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR