BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL MODULE

    MDR report key: 2894948 · Received January 3, 2013

    Report

    Report Number
    2015691-2013-18996
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K00664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED CABLE IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT OF THE SVO2 VALUE BECOMING UNSTABLE DURING USE AND DRIFTING FROM 60% TO 80% DURING 5 (FIVE) MINUTES WITH NO MESSAGES BEING OBSERVED COULD NOT BE CONFIRMED THROUGH EVALUATION OF THE RETURNED DEVICE. EXAMINATION OF THE RETURNED OM2 WAS UNABLE TO DETECT ANY FAILURE OF THE DEVICE TO FUNCTION AS INTENDED. THE CABLE WAS TESTED PER THE ESTABLISHED SOP REQUIREMENTS AND INVITRO AND INVIVO CALIBRATIONS WERE EXECUTED SUCCESSFULLY. SVO2 WAS MONITORED FOR OVER 30 MINUTES WITH NO ISSUES OBSERVED. NO PHYSICAL DAMAGE WAS DETECTED DURING THE VISUAL INSPECTION OF THE CABLE. THE CABLE WAS MANUFACTURED 31-MARCH-2011 AND REVIEW OF THE DEVICE HISTORY RECORD SUPPORTS THAT THERE WERE NO NON-CONFORMANCES NOTED DURING THE MANUFACTURING OF THE DEVICE FOR ANY REASON. IT IS UNKNOWN WHETHER PROCEDURAL PROCESSES OR A SPECIFIC CIRCUMSTANCE PLAYED A ROLE IN THE CUSTOMER'S EXPERIENCE, AS NO FAULT COULD BE DETERMINED AND THERE WAS NO EVIDENCE OF ANY FAILURE OF THE REFERENCED DEVICE TO FUNCTION AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF AN OM2 CABLE, THE SVO2 VALUE BECAME UNSTABLE AND DRIFTED FROM 60% TO 80% DURING APPROXIMATELY 5 MINUTES, WITH NO ERROR MESSAGES OBSERVED. MAP AND ECG WERE NOT AFFECTED WHILE SVO2 DRIFTED. SUBSEQUENTLY, THE CABLE WAS REPLACED AND THE ISSUE WAS IMMEDIATELY RESOLVED. NO PATIENT COMPROMISE WAS REPORTED AND NO ADDITIONAL SYSTEM-RELATED DEVICES WERE IDENTIFIED AS SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254 OPTICAL MODULE OXIMETRY CABLE DXG EDWARDS LIFESCIENCES OM2

    Patients

    Seq Age Sex Outcome Treatment
    1