BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3843545 · Received March 14, 2014

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    Report

    Report Number
    2936999-2014-00245
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 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 VERIFIED THE FINDING OF MISSING SEGMENTS. THE UNIT WAS DISASSEMBLED AND VISUAL INSPECTION FOUND COLD SOLDER JOINTS ON THE DISPLAY PCB. THE DISPLAY PCB WAS REPLACED. SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN TECHNICIAN DISCOVERED THE MISSING SEGMENTS ON THE DISPLAY WHEN THE UNIT CAME IN FOR SERVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154075 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1