BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSAT PULSE OXIMETER AND ACCESSORIES

    MDR report key: 1907727 · Received November 16, 2010

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    Report

    Report Number
    9613557-2010-00009
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    August 4, 2010
    Report Date
    November 16, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    DPZ
    PMA / PMN Number
    K040831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CHILD WAS BEING MONITORED ON A TRUSAT PULSE OXIMETER USING AN OXYTIP FINGER SENSOR. THE PT'S MOTHER REPORTEDLY HEARD THE CHILD "GASPING" AND FOUND THE CABLE FROM THE PROBE WRAPPED AROUND THE CHILD'S NECK. THE MOTHER REMOVED THE PROBE AND THE PT SUFFERED NO LASTING HARM. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUSAT PULSE OXIMETER AND ACCESSORIES PULSE OXIMETER DPZ GE HEALTHCARE 6051-0000-193

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention OXYTIP+FINGER SENSOR