BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX DS100A DURASENSOR

    MDR report key: 3815355 · Received March 27, 2014

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    Report

    Report Number
    2936999-2014-00294
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CALLER (BIOMED) STATED THAT SENSOR WAS RETURNED TO THE BIOMED WITHIN THE LAST TWO MONTHS. IT HAD BEEN REPORTED THAT THIS DS100A SENSOR WAS GIVING LOW READINGS WHILE MONITORING A PATIENT. IT WAS NOT REPORTED WHAT THE ACTUAL READING VALUE WA NOR WAS IT REPORTED IF IT WAS PULSE RATE OR SPO2 RATE THAT WERE LOW. CALLER STATED THAT NO FURTHER INFORMATION WAS AVAILABLE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179731 OXIMAX DS100A DURASENSOR ADULT OXYGEN SENSOR DPZ COVIDIEN 2048069X

    Patients

    Seq Age Sex Outcome Treatment
    1