BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIR

    MDR report key: 1755417 · Received June 16, 2010

    Report

    Report Number
    1625774-2010-00048
    Event Type
    Malfunction
    Date Received
    June 16, 2010
    Date of Event
    February 28, 2010
    Report Date
    May 17, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010, AFTER COMPLAINT INVESTIGATION, IT WAS FOUND THAT THE KINAIR MEDSURG LOW AIR LOSS THERAPY DID NOT HAVE ANY DEFECT, AND IT PASSED QUALITY CONTROL SPECIFICATIONS. BOTH KCI FIELD SERVICE TECHNICIAN AND KCI FIELD RELIABILITY ENGINEER FOUND THAT THERE WERE NO ISSUES WITH THE BED BRAKE/STEER MECHANISM. THE BED HAS BEEN SUBSEQUENTLY PLACED WITH THREE ADDITIONAL PTS WITHOUT ANY MALFUNCTION RELATED TO THE REPORTED ISSUE. SINCE THE REPORTED INCIDENT, THE BED HAS BEEN RETESTED THREE ADDITIONAL TIMES PER QUALITY CONTROL PROCEDURES ON THESE DATES (B)(4) 2010 AND WAS FOUND TO MEET SPECIFICATION IN EACH CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS PLACED ON THE KINAIR MEDSURG LOW AIR LOSS THERAPY. ON (B)(6) 2010, THE FACILITY REPORTED THAT ON (B)(6) 2010, THE WHEELS WOULD NOT LOCK ON A KINAIR MEDSURG LOW AIR LOSS THERAPY IN SURGICAL INTENSIVE CARE UNIT. WHEN THE CARE GIVER LEANED ON THE BED, IT WOULD EASILY MOVE. ON (B)(6) 2010, THE SERVICE WORK ORDER WAS CREATED AND THE KCI FIELD SERVICE CONSULTANT DETERMINED THAT BOTH PT LEFT FOOT AND RIGHT HEAD CASTER BRAKES REQUIRED ADJUSTMENT. THE FIELD SERVICE CONSULTANT ADJUSTED THE BRAKES AND TESTED THE BRAKE/STEER MECHANISM TO ENSURE THAT THERE WAS NO BED MOVEMENT WHEN THE BRAKES WERE APPLIED. THE REPORTED ISSUE WAS RESOLVED BY THE KCI FIELD SERVICE CONSULTANT BY ADJUSTING THE HEAD END CASTER BRAKE. ON (B)(6) 2010, THE PT WAS TAKEN OFF THE BED. ON (B)(6)2010, THE KCI RELIABILITY ENGINEER WENT TO THE SERVICE CENTER TO FURTHER EVALUATE THE BED. THE FRAME PASSED THE QC AND WAS QUARANTINED FOR EVALUATION. THE BRAKE SYSTEM WAS INSPECTED AND NO MECHANICAL DEFECTS WERE FOUND. THE CASTERS WERE IN GOOD WORKING ORDER AND NO SIGNS OF WEAR OR BROKEN COMPONENTS WERE NOTED. THE BRAKE/STEER ADJUSTMENT OPERATED CORRECTLY. WHEN PLACED INTO STEER, THE BRAKE/STEER CASTER LOCKED INTO PLACE. WHEN PLACED INTO BRAKE, THE BRAKE CASTER PROVIDED RESISTANCE TO MOVEMENT AND THE BRAKE/STEER CASTER PROVIDED RESISTANCE TO MOVEMENT. DURING THE EVAL, THE BED OPERATED AS DESIGNED AND NO DEFECTS WERE NOTED. THERE WAS NO REPORTED INJURY OF DEATH WITH THIS REPORT. IT IS BEING REPORTED FOR THE POTENTIAL FOR AN EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1