BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 2844732 · Received November 8, 2012

    Report

    Report Number
    2936999-2012-00582
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    N-560 OPERATOR'S MANUAL CONTAINS: CAUTION: IF ANY INDICATOR OR DISPLAY ELEMENT DOES OT LIGHT, OR THE SPEAKER DOES NOT SOUND, DO NOT USE THE N-560. INSTEAD, CONTACT QUALIFIED SERVICE PERSONNEL, YOUR LOCAL NELLCOR REPRESENTATIVE, OR NELLCOR'S TECHNICAL SERVICES DEPARTMENT, (B)(4). CAUTION: DURING POST (IMMEDIATELY AFTER POWER-UP), CONFIRM THAT ALL DISPLAY SEGMENTS AND INDICATORS LIGHT, AND THE SPEAKER SOUNDS A 1-SECOND PASS TONE.

    Description of Event or Problem · 1

    COVIDEIN RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER STATING THAT THE N-560 INITIALLY DID NOT HAVE ANY AUDIO. THE BIOMED WAS ABLE TO RAISE THE VOLUME OF THE PULSE TONE AND ALARM, AND EVENTUALLY DID GET A FAINT TONE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR HARM. THE BIOMED HAD REPLACED THE SPEAKER, BUT THIS DID NOT RESOLVE THE ISSUE. THE CUSTOMER STATES THAT THE SERIAL NUMBER OF THIS N560 WAS ILLEGIBLE AND COULD NOT LONGER BE READ; THE BACK LABEL STATES THE YEAR 2007. CALLER DECLINED TO RETURN PRODUCT TO COVIDIEN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1