BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX NEONATAL/ADULT OXYGEN SENSOR

    MDR report key: 3102293 · Received April 29, 2013

    Report

    Report Number
    2936999-2013-00319
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K052186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN: 'THIS IS NOT A COMPLAINT BUT A REPORT OF ABNORMAL TEST RESULTS PERFORMED AT OUR CUSTOMER'S INSTITUTION. THE SENSORS TESTED (NOT ON PT) WITH A CALIBRATION MACHINE GAVE LOWER RESULTS THAN IT SHOULD HAVE. EXAMPLE, SPO2 77% WHEN IT SHOULD HAVE BEEN 80% OR 69% FOR 75%. WHEN THE TESTS WERE PERFORMED WITH A DIFFERENT LOT NUMBER (122890017), WE DID NOT GET ANY DIFFERENCES.' NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184177 OXIMAX NEONATAL/ADULT OXYGEN SENSOR OXIMAX MAXN OXYGEN SENSOR DQA COVIDIEN, FORMERLY TYCO HEALTHCARE MAXNI 2055064X

    Patients

    Seq Age Sex Outcome Treatment
    1