BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL MODULE II

    MDR report key: 1901230 · Received November 17, 2010

    Report

    Report Number
    2015691-2010-14388
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    ISN
    PMA / PMN Number
    K43103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPTICAL MODULE WAS RETURNED TO AN EDWARDS ELECTRONICS SERVICE CENTER FOR EVALUATION. AN EDWARDS ELECTRONIC TECHNICIAN EVALUATED THE OPTICAL MODULE AND CONFIRMED SVO2 DRIFTING. UPON FURTHER INVESTIGATION IT WAS FOUND THAT THE TRILENS (OPTICAL LENS) WAS DAMAGED/BROKEN AND THAT A RAINBOW COLOR WAS NOTED CAUSING THE SVO2 DRIFT. ALTHOUGH THE ROOT CAUSE FOR THIS DAMAGE CANNOT BE DETERMINED, THERE ARE MULTIPLE POTENTIAL CAUSES FOR A DAMAGED TRILENS, INCLUDING: MISUSE - DROPPING, NORMAL WEAR AND TEAR, BLOOD SPILLAGE, MISUSE OF CHEMICALS TO CLEAN THE LENS. THIS PARTICULAR OM2 IS APPROX 6 - 1/2 YEARS OLD. SINCE (B)(6) 2009, THIS TYPE OF PRODUCT CARRIES AN EXPIRATION DATING OF 42 MONTHS. THE FAULTY CABLE CANNOT BE REPAIRED AND WAS DECOMMISSIONED. THE SERVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED AND IT WAS CONFIRMED THAT ALL MANUFACTURING REQUIREMENTS WERE MET AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE PRODUCT BUT COULD NOT STATE WHAT THE PROBLEM WAS. NO PATIENT INJURY WAS REPORTED. ADDENDUM: ANALYSIS OF THE RETURNED PRODUCT CONFIRMED SVO2 DRIFTING.

    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