BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONIN

    MDR report key: 1403307 · Received June 8, 2009

    Report

    Report Number
    2183646-2009-00002
    Event Type
    Other
    Date Received
    June 8, 2009
    Date of Event
    May 12, 2009
    Report Date
    June 5, 2009
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K040589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VISIT TO THE PEDIATRICIAN, A RN WAS CHECKING THE INFANT'S HEART RATE AND STARTED CPR IN THE OFFICE AT THAT TIME. THE INFANT WAS TRANSPORTED TO SOMERSET HOSPITAL AND SUBSEQUENTLY TO CHILDREN'S HOSPITAL WHERE THE INFANT REMAINS AT THE PRESENT. THE MOTHER STATED THAT DURING THE OFFICE VISIT THE OXIMETER DID NOT ALARM PRIOR TO THE RN STARTING CPR. IT IS UNKNOWN IF THE PROBE (SENSOR) THAT WAS IN USE AT THE TIME WAS THE ONE FROM THE HOSPITAL OR ONE OF THE PROBES THE DME SENT TO THE MOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN PULSE OXIMETER AND SENSOR DQA NONIN MEDICAL, INC. 9600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L