BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 3716225 · Received February 28, 2014

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    Report

    Report Number
    2936999-2014-00187
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    January 4, 2014
    Report Date
    February 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT RETURNED TO COVIDIEN. THE PRODUCT IS AT END OF SERVICE AND WITHOUT PARTS AVAILABLE TO SEND TO THE CUSTOMER FOR REPAIR. A SIMILAR INVESTIGATION HAS BEEN PERFORMED IN 2936999-2011-00137, (B)(4). COVIDIEN HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER, BUT HAS RECEIVED NO FURTHER INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN EVENT DESCRIPTION: POST THORACOTOMY PT WAS RECEIVING MULTIPLE PAIN MEDICATIONS REQUIRING A CONTINUOUS PULSE OXIMETRY. THE PULSE OXIMETER FAILED TO ALARM TO NOTIFY THE RN THAT THE PT'S OXYGEN SATURATION LEVEL DROPPED TO 48%, ONCE RN NOTICED, SHE INTERVENED BY CALLING A CODE BLUE FOR ASSISTANCE. THE PT WAS INTUBATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PT WAS EXTUBATED THE FOLLOWING DAY AND HAS BEEN DISCHARGED AT THIS POINT IN TIME WITHOUT ANY PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124977 OXIMAX N-595 PULSE OXIMETER PULSE OXIMETER DPZ COVIDIEN N-595

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R