BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE OXIMETER

    MDR report key: 1051076 · Received May 21, 2008

    Report

    Report Number
    2936999-2008-00231
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 1, 2006
    Report Date
    April 24, 2008
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE DEVICE BECOMES AVAILABLE FOR INVESTIGATION, THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CO RECEIVED A REPORT THAT AN UNSPECIFIED MODEL PULSE OXIMETER FAILED TO PROVIDE OXYGEN READINGS DURING PT USE, RESULTING IN THE PT'S HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXIMETER NONE DQA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization