BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3082562 · Received April 24, 2013

    Report

    Report Number
    2936999-2013-00313
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SERVICE CENTER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM, HOWEVER, THEY REPLACED THE FRONT BOARD FOR THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A MISSING SEGMENT OF THE DISPLAY, WHERE A READING WAS UNCLEAR TO THE USER IF THE VALUE WAS AT 97 PERCENT OR IF AT 91 PERCENT SATURATION. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176216 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1