BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL MODULE II

    MDR report key: 1891226 · Received November 4, 2010

    Report

    Report Number
    2015691-2010-14315
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    ISN
    PMA / PMN Number
    K043103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPTICAL MODULE WAS RETURNED TO THE EDWARDS ELECTRONICS SERVICE CENTER FOR EVALUATION. AN EDWARDS ELECTRONIC TECHNICIAN EVALUATED THE OPTICAL MODULE AND FOUND THAT THE ERROR CODE WAS IN-VITRO CALIBRATION. THE "SVO2 DRIFT" WAS NOT VERIFIED. UPON FURTHER INVESTIGATION THE OPTICAL MODULE WAS FOUND TO HAVE PHYSICAL DAMAGE. THE CABLE SHIELD WAS "OPEN" DUE TO CABLE PIN #5 MISSING, CAUSING THE IN-VITRO CALIBRATION ERROR. THERE IS NO SERVICE HISTORY RECORD FOR THIS DEVICE AS THIS WAS THE FIRST TIME THE CABLE WAS SENT TO EDWARDS FOR SERVICING. HOWEVER, BASED ON THE SERIAL NUMBER OUR RECORDS SHOW THE CUSTOMER ACQUIRED THE PRODUCT ON (B)(6) 1997 THUS THE OM2 IS APPROX 13 YEARS OLD. AS OF (B)(6) 2009, THIS TYPE OF PRODUCT CARRIES A USE BY DATE OF 42 MONTHS. THE PHYSICAL DAMAGE THAT WAS CONFIRMED ON THE RETURNED PRODUCT CAN OCCUR DUE TO NORMAL WEAR AND TEAR AND/OR MIS-HANDLING OF THE PRODUCT. THE FAULTY CABLE CANNOT BE REPAIRED AND WAS DECOMMISSIONED.

    Description of Event or Problem · 1

    OPTICAL MODULE, MODEL OM-2, SERIAL NUMBER (B)(4) WAS REPORTED BY CUSTOMER AS "SVO2 DRIFTING. DOES NOT HOLD CALIBRATION". NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL MODULE II OPTICAL MODULE/OXIMETRY CABLE ISN EDWARDS LIFESCIENCES OM2

    Patients

    Seq Age Sex Outcome Treatment
    1