BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOXIMETER 4000 W/110V AC ADAPTER

    MDR report key: 4756846 · Received May 5, 2015

    Report

    Report Number
    2248721-2015-00029
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JKS
    PMA / PMN Number
    K951485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE ACTUAL DEVICE WAS EVALUATED. PROCESS EVALUATION WAS PERFORMED. NO REPORTS OF NON-CONFORMANCE OR OTHER ANOMALIES RELATED TO THE COMPLAINT WERE IDENTIFIED. RESULTS: MAINTENANCE PROBLEM. PRECISION OF THE DEVICE WAS FOUND TO BE OUTSIDE ACCEPTABLE LIMITS. INSTRUMENT REPAIR AND RECALIBRATION IS REQUIRED. CONCLUSION: OUT OF CALIBRATION. THE INSTRUMENT FAILED WET QC TESTING AND WILL BE SENT FOR REPAIR. WHEN IT IS RETURNS FROM REPAIR, IT WILL UNDERGO REPEAT QC TESTING TO DETERMINE IF INSTRUMENT RE-CALIBRATED IS REQUIRED TO MEET PRECISION SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR SUMMARIZES THE RESULTS OF (B)(4) WHICH REPORTS RESULTS OF THE SECOND DEVICE EVALUATION. THIS MDR REFERENCES ITC COMPLAINT NUMBER (B)(4). METHOD: THE ACTUAL DEVICE WAS EVALUATED. INSTRUMENT WAS SERVICED AND WAS RETURNED TO ITC FOR RE-EVALUATION. RESULTS: MECHANICAL PROBLEM. DEVICE FAILED WET QUALITY CONTROL TESTING. INSTRUMENT REPAIR AND RECALIBRATION REQUIRED. CONCLUSION: OUT OF CALIBRATION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INCONSISTENT CARBOXYHEMOGLOBIN RESULTS FROM AN AVOXIMETER 4000 SYSTEM. CO-OXYMETRY TESTING WAS PERFORMED ON A PATIENT OF UNK GENDER, AGE, WEIGHT, HEIGHT OR DIAGNOSIS. THE TEST WAS REPEATED MULTIPLE TIMES BECAUSE THE INITIAL VALUE WAS NOT CONSISTENT WITH EXPECTATIONS, AND REPEAT RESULTS WERE INCONSISTENT WITH SUBSEQUENT TESTING. SYSTEM OPERATION AND SAMPLE HANDLING APPEARED APPROPRIATE BASED ON THE AVOXIMETER USER MANUAL. LIQUID AND OPTICAL QUALITY CONTROL TESTS PASSED SUCCESSFULLY. THE ACCURACY GUIDELINES FOR CARBOXYHEMOGLOBIN RESULTS RECOMMENDED BY CLIA IS <=3.0%. THE ABSOLUTE DIFFERENCE BETWEEN RESULTS (LOWEST VALUE COMPARED TO THE HIGHEST VALUE) WAS 3.4%, THUS EXCEEDING THE LIMIT OF ACCURACY. THE INSTRUMENT WAS RETURNED TO ITC FOR EVALUATION. PATIENT DEATH DID NOT OCCUR AND THERE WERE NO SERIOUS INJURIES OR OTHER COMPLICATIONS RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293447 AVOXIMETER 4000 W/110V AC ADAPTER CARBON MONOXIDE TEST SYSTEM JKS INTERNATIONAL TECHNIDYNE CORP. AVOX4000-110

    Patients

    Seq Age Sex Outcome Treatment
    1