BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXISENSOR II, N25

    MDR report key: 3871194 · Received April 14, 2014

    Report

    Report Number
    2936999-2014-00339
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    PMA / PMN Number
    K993637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST NOTIFIED COVIDIEN THAT WHILE TRAINING A PARENT TO MONITOR THEIR CHILD AT HOME, SHE PLACED THE N25 SENSOR ON PT AND IT GAVE LOW READINGS. THE PT READ 84% SPO2 ON THE BCI MONITOR WITH THE N25 SENSOR BUT WITH A MAXA SENSOR, PT DEAD 94%. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228220 OXISENSOR II, N25 OXISENSOR II, NEONATAL/ADULT SENSOR DQA COVIDIEN 132910189X

    Patients

    Seq Age Sex Outcome Treatment
    1 BCI MONITOR