BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3042284 · Received April 3, 2013

    Report

    Report Number
    2936999-2013-00259
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    NELLCOR PRITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN SVC CTR VERIFIED THE REPORT OF NO AUDIO AND ISOLATED THE PROBLEM TO A BROKEN BLACK LEAD WIRE OF THE SPEAKER ASSEMBLY.

    Description of Event or Problem · 1

    COVIDIEN REC'D A REPORT OF A N-560 THAT DID NOT GENERATE SOUND. COVIDIEN SVC CTR CONFIRMED THAT THE REPORT WAS FOR NO AUDIO. NO PT INVOLVEMENT, THE REPORTED FAILURE OCCURRED DURING A DEMONSTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137370 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PRITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1