BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3871346 · Received April 21, 2014

    Report

    Report Number
    2936999-2014-00321
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN ENGINEER COULD NOT DUPLICATE THE CUSTOMER'S COMPLAINT THAT THE DISPLAY WAS MISSING SEGMENTS. THE UNIT WAS POWER CYCLED SEVERAL TIMES AND ALL THE SEGMENTS SHOWED. THE UNIT WAS ALLOWED TO RUN FOR SEVERAL DAYS AND ALL THE SEGMENTS SHOWED DURING THE RUN. THE UNIT WAS POWER CYCLED MULTIPLE TIMES AGAIN, AND ALL THE DISPLAY SEGMENTS SHOWED. VISUAL INSPECTION SHOWED POSSIBLE SOLDER ISSUES ON THE MAIN AND DISPLAY PCBS. THE MAIN AND DISPLAY PCBS WERE REPLACED AS A PRECAUTION. (B)(4). THE SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT WAS MISSING DISPLAY SEGMENTS. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241392 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1