BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXOXIMETER 4000

    MDR report key: 7173967 · Received January 8, 2018

    Report

    Report Number
    2250033-2018-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 5, 2017
    Report Date
    April 13, 2018
    Manufacturer
    ACCRIVA DIAGNOSTICS
    Product Code
    JKS
    UDI-DI
    10711234530054
    PMA / PMN Number
    K951485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PATIENT WEIGHT WAS NOT SPECIFIED - PLEASE DELETE THE (B)(6) VALUE PREVIOUSLY ENTERED.

    Additional Manufacturer Narrative · 0

    MDR 2250033-2018-00004 FOLLOW-UP #1 REFERENCES ACRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) FOR AVOXIMETER 4000 CO-OXIMETER SERIAL NUMBER (B)(4), WHICH WAS EVALUATED IN RESPONSE TO THE CUSTOMER'S COMPLAINT. (B)(4). ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM FDA 3500-A. NO PREVIOUSLY UNOBTAINABLE INFORMATION REPORTED IN THE INITIAL MDR IS AVAILABLE.

    Description of Event or Problem · 0

    FOLLOW-UP #2.

    Description of Event or Problem · 0

    FOLLOW-UP #1.

    Additional Manufacturer Narrative · 1

    THIS MDR REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) FOR AVOXIMETER 4000 CO-OXIMETER SERIAL NUMBER (B)(4). A CHILD CASE CAPTURING THE CUVETTE AND LOT NUMBER OF THE DISPOSABLE DEVICE TESTED WITH THIS INSTRUMENT IS 7053171-31711 AND IS REFERENCED BY ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4). ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION WAS PERFORMED. DHR REVIEWED SHOWED NO NCRS, CAPAS, INSTRUMENT REPAIRS OR OTHER ANOMALIES RELATED TO THIS COMPLAINT. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE NOT RETURNED. ACCRIVA HAS REQUESTED ALL DATA REQUIRED FOR FORM FDA 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN UNEXPECTEDLY HIGH %COHB RESULT WITH AN AVOXIMETER 4000 CO-OXIMETER IN A CONTINUOUSLY VENTILATED NURSING HOME PATIENT. BLOOD GASES AND CO-OXIMETRY TESTS WERE BEING CONDUCTED EVERY 12 HOURS. TEST RESULTS WERE AS EXPECTED EXCEPT FOR ONE UNEXPECTEDLY HIGH %COHB RESULT (5.2%) THAT WAS CLINICALLY SIGNIFICANT AND ABOVE THE PATIENT'S 48-HOUR BASELINE %COHB OF 2.1%. THE PATIENT RECEIVED AN UNSPECIFIED TREATMENT AND SUBSEQUENT BLOOD GASES AND CO-OXIMETER RESULTS RETURNED TO BASELINE. AN INTERNAL INVESTIGATION DID NOT FIND ANY EVIDENCE THAT THE PATIENT WAS EXPOSED TO CARBON MONOXIDE. NO MEDICAL COMPLICATIONS OR OTHER EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15360 AXOXIMETER 4000 SPECTRAL ABSORB. CURVE, OXYHEMOGLOBIN, CARBOXYHEMOGLOBIN, CARBON MONOXIDE JKS ACCRIVA DIAGNOSTICS AVOX4000 10711234530054

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR AVOX4000 QV8 CUVETTES