BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX ANALYZER

    MDR report key: 2544480 · Received April 5, 2012

    Report

    Report Number
    2027541-2012-00010
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Report Date
    November 17, 2011
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    JJY
    PMA / PMN Number
    K051804
    Removal / Correction Number
    2027541-02/03/2012-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THIS UNIT IS PART OF A RECALL (REPORTED TO FDA ON (B)(4) 2012, 2027541-02/03/2012-R) AND HAS NOT BEEN PHYSICALLY EVALUATED. INVESTIGATIONS FROM SIMILAR UNITS THAT ARE PART OF THE SAME RECALL HAVE REVEALED THAT THERE IS A POTENTIAL ELECTRONIC PROBLEM CONCERNING THE SIGNAL DATA BOARD ((B)(4)). SOME BOARDS ARE SUSCEPTIBLE TO A VOLTAGE SPIKE WHICH CAN INDUCE AN ERROR CONDITION. THIS CONDITION CAN OCCUR DURING NORMAL USE AND WITHOUT WARNING AND CAN LEAD TO CALIBRATIONS FAILURES FOR THE PH, PCO2, CNA+, CK+, CCA2+, AND CCL SENSOR CHANNELS. THERE HAVE BEEN NO REPORTED CASES FOR MISTREATMENT OR INJURIES ASSOCIATED WITH THIS ISSUE. AS OF (B)(4) 2012, THIS UNIT HAS BEEN CORRECTED (REPLACEMENT OF PC BOARDS) AS PART OF THE RECALL CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A DISTRIBUTOR REPORTED THAT 12 ABL80 FLEX ANALYZERS WERE EXHIBITING INTERMITTENT PROBLEMS WITH MULTI-SENSITIVITY ERRORS WITH ISE SENSORS. THIS IS THE 6TH MEDWATCH REPORT FOR THE 12 ANALYZERS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL80 FLEX ANALYZER PH, BLOODGAS, ELECTROLYTE ANALYSIS SYSTEM JJY SENDX MEDICAL, INC. 393-839

    Patients

    Seq Age Sex Outcome Treatment
    1