BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXIMETRY OPTICAL MODULE

    MDR report key: 2311932 · Received October 27, 2011

    Report

    Report Number
    2015691-2011-16348
    Event Type
    Injury
    Date Received
    October 27, 2011
    Date of Event
    September 18, 2011
    Report Date
    September 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE PRODUCT WAS RETURNED FOR EVALUATION. THE CAUSE OF THE FAILURE APPEARS TO BE EXCESSIVE FORCE TO THE CABLE WHEN CONNECTING THE CABLE TO THE MONITOR. THIS CAUSED CABLE PIN #7 TO BECOME BENT AND TO SHORT OUT PIN #8, WHICH CAUSED THE CABLE TO MALFUNCTION; THIS WOULD CAUSE A TEMPERATURE ERROR MESSAGE TO APPEAR ON THE MONITOR. WHEN A TEMPERATURE ERROR APPEARS ON THE MONITOR, IT IS AN INDICATOR THAT THE CABLE IS NOT IN WORKING CONDITION AND THE OM2 MODULE MAY BECOME WARM. A SHORT CONDITION FROM THIS TYPE OF DAMAGE CAN CAUSE BLOCK U6 IN THE CABLE TO BECOME WARM. THE DEVICE WAS TAKEN OUT OF SERVICE AND DESTROYED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6CM SEROUS FILLED BLISTER WAS NOTED ON THE RIGHT POSTERIOR SHOULDER WITH ERYTHEMA EXTENDING ANOTHER 3CM. THE OPTICAL MODULE (OM2) CABLE WAS NOTED TO BE IN CLOSE VICINITY AND WHEN THE NURSE PICKED IT UP, IT WAS VERY HOT TO THE TOUCH. THE OM2 WAS CHANGED OUT AND MONITORING PROCEEDED WITHOUT FURTHER INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1