BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVOXIMETER 1000E WHOLE BLOOD OXIMETER

    MDR report key: 2217061 · Received July 15, 2011

    Report

    Report Number
    2248721-2011-00087
    Event Type
    Other
    Date Received
    July 15, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    DQA
    PMA / PMN Number
    K922075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - USER FACILITY FEEDBACK WAS EVALUATED. RESULT - AS STATED IN THE AVOXIMETER 1000E OPERATOR'S MANUAL (PAGE 34) AND DURING INSTALLATION TRAINING SESSIONS PROVIDED BY ITC, THE OPERATOR WAS TEST EACH OPTICAL FILTER WITH THE INSTRUMENT OF THE SAME SERIAL NUMBER. FOR EASE OF USE, THE OPERATOR CAN MATCH THE SERIAL NUMBER OF THE FILTER TO THE SERIAL NUMBER THAT IS AFFIXED TO THE BACK OF THE AVOXIMETER INSTRUMENT. THE SET OF OPTICAL FILTERS (YELLOW AND ORANGE) IS A CONVENIENT MEANS OF VERIFYING THAT THE OPTICS OF THE AVOXIMETER ARE NOT OBSCURED BY BLOOD OR DEBRIS AND THAT THE INSTRUMENT IS PROPERLY CALIBRATED. PERFORMING OPTICAL QUALITY CONTROL TESTING IS SIMILAR TO PERFORMING A PATIENT TEST. THE OPTICAL FILTERS ARE EXCHANGED FOR TEST CUVETTES AND NO SPECIMEN IS REQUIRED. THE FILTERS SIMULATE A CUVETTE CONTAINING A BLOOD SAMPLE OF KNOWN CHEMISTRY. CONCLUSION: RETENTION OF THE FILTERS AS DESCRIBED IN THE MEDWATCH REPORT MAY SCRATCH, BREAK, OR OTHERWISE DAMAGE THE INSTRUMENT AND/OR THE FILTERS, OR THE FILTERS MAY BE LOST DURING INSTRUMENT TRANSIT. ITC RECOMMENDS THAT THE FILTERS BE RETAINED IN THE PROTECTIVE CONTAINER DESIGNED FOR THIS PURPOSE AND BE STORED IN A SAFE, CONVENIENT LOCATION FOR DAILY USE.

    Description of Event or Problem · 1

    THIS IS A MANUFACTURER'S FOLLOW UP REPORT TO THE USER FACILITY REPORT, RECEIVED BY ITC ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVOXIMETER 1000E WHOLE BLOOD OXIMETER DQA INTERNATIONAL TECHNIDYNE CORP. AVOX1000E110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other