BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX WITH BASIC SOFTWARE ANALYZER

    MDR report key: 4239187 · Received October 31, 2014

    Report

    Report Number
    2027541-2014-00007
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    September 2, 2014
    Report Date
    October 3, 2014
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    PMA / PMN Number
    K051804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) VISITED CUSTOMER AND REPLACED THE SIGNAL DATA BOARD AND SENSOR BOARD. THE ISSUE WAS NOT RESOLVED. AFTER THE FSE VISIT CUSTOMER REPLACED THE SENSOR CASSETTE AND SOLUTION PACK, AND THE ABL80 ANALYZER IN QUESTION WAS WITHIN 0.5 KPA OF THE ABL800 ANALYZER. THERE HAVE BEEN NO MORE REPORTED COMPLAINTS FROM THE CUSTOMER RELATED TO THIS INCIDENT. MULTIPLE REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE SENSOR CASSETTE AND ADD'L DATA LOGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ABL80 FLEX (WITH BASIC SOFTWARE) ANALYZER GENERATED SIGNIFICANTLY HIGHER PO2 RESULTS FOR BLOOD SAMPLE COMPARISONS FROM (B)(6) 2014 WHEN COMPARED TO ANOTHER ABL80 ANALYZER AND AN ABL800 ANALYZER. CUSTOMER STATED THAT THE ANALYZER WAS CONSISTENTLY PASSING QC, AND ALL OTHER PARAMETERS WERE WITHIN RANGE. THERE WAS ALSO NO REPORTED INJURY, DIAGNOSIS OR TREATMENT BASED ON THE HIGH PO2 RESULTS. ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698358 ABL80 FLEX WITH BASIC SOFTWARE ANALYZER ELECTRODE MEASUREMENT, BLOOD-GAS, PH CHL SENDX MEDICAL, INC. ABL80 FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1