BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HP PHILIP CENTRAL M315OA PULSE OXIMETER

    MDR report key: 2281566 · Received October 3, 2011

    Report

    Report Number
    MW5022503
    Event Type
    Injury
    Date Received
    October 3, 2011
    Date of Event
    September 27, 2011
    Report Date
    October 3, 2011
    Manufacturer
    PHILIPS
    Product Code
    OLK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS IN INTENSIVE CARE UNIT ON MONITORS: THE ABG IN THE MORNING WAS WITHIN NORMAL LIMITS. A SECOND ABG WAS TAKEN AND CAME AT 74%, HOWEVER, THE HP PHILLIPS CENTRAL M315OA PULSE OXIMETER WAS READING 100%. A PORTABLE OXIMETRY SYSTEM WAS PLACED ON PT AND A 74% OXYGEN LEVEL WAS NOTED AS A DOUBLE CHECK. DATES OF USE: (B)(6) 2001 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HP PHILIP CENTRAL M315OA PULSE OXIMETER PULSE OXIMETER OLK PHILIPS M315OA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S