BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1679341 · Received April 30, 2010

    Report

    Report Number
    3004147784-2010-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Product Code
    JOJ
    PMA / PMN Number
    K031647
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BIOSIGN TEST PACK PROVIDES BIOLOGICAL TESTING AND MONITORING ON PRE-VACUUM STERILIZATION CYCLES WHICH INCLUDES INSTANT VERIFICATION THAT A PARTICULAR STERILIZATION CYCLE WAS EXPOSED TO STERILIZATION PARAMETERS AND A BIOLOGICAL INDICATOR WITH GROWTH MEDIA THAT REQUIRES A 24 HR INCUBATION PERIOD. THE REPORT STATED THAT THE INTEGRATOR DID NOT COMPLETELY TURN GREEN. INSTRUCTIONS FOR USE STATE THAT A PASS IS DEMONSTRATED BY AN INTEGRATOR COLOR CHANGE FROM PURPLE TO GREEN. IF THE GREEN IS NOT OBSERVED, HAVE THE STERILIZER CHECKED FOR PROPER OPERATION, THEN REPEAT THE TEST. THE COLOR NOT CHANGING TO GREEN INDICATES A FAILURE OF A STERILIZERS' CYCLE REACHING THE REQUIRED STERILIZATION PARAMETERS AND IS NOT CONSIDERED A MALFUNCTION OF THE INTEGRATOR. THE INVESTIGATION IS CONTINUING AND A FOLLOW UP REPORT TO BE SUBMITTED UPON CONCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE JOJ

    Patients

    Seq Age Sex Outcome Treatment
    1