BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR ADULT SPO2 SENSOR

    MDR report key: 5394101 · Received January 18, 2016

    Report

    Report Number
    MW5059664
    Event Type
    Malfunction
    Date Received
    January 18, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 18, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    STAFF NOTED PATIENT PULSE OX PROBE READING DIDN'T MATCH THE PATIENT CONDITION. THE READING WITH THE DISPOSABLE PROBE ON SPACE LABS MONITOR WAS FLUCTUATING BETWEEN 83-88%. PATIENT WAS PLACED ON BIPAP AND EBG WAS DONE WHICH ALSO DIDN'T MATCH THE MONITOR READING. STAFF CHECKED PULSE OX WITH A NON-DISPOSABLE PROBE AND RECEIVED A 94% READING. THE DISPOSABLE PROBES WERE REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34376 NELLCOR ADULT SPO2 SENSOR NELLCOR ADULT SPO2 SENSOR DQA MEDTRONIC MAXA 153310033H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other