BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N65 PULSE OXIMETER

    MDR report key: 1963806 · Received December 22, 2010

    Report

    Report Number
    2936999-2010-01402
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 22, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K051352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SERVICE FOR AN UNRELATED FAILURE, IT WAS NOTICED THAT THE DEVICE HAD NO AUDIO. IT WAS VERIFIED THAT THE UI PCB WAS CAUSING THE FAILURE. IT HAS BEEN REQUESTED THAT THE BOARD BE SENT TO THE MFR FOR FAILURE INVESTIGATION. IF NEW INFO IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE SERVICE OF THE DEVICE FOR AN UNRELATED COMPLAINT, IT WAS NOTICED THAT THE DEVICE HAD NO AUDIO. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N65 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N65

    Patients

    Seq Age Sex Outcome Treatment
    1