BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDISAT - CENTRAL VENOUS OXIMETRY CATHETER KIT

    MDR report key: 1052004 · Received May 21, 2008

    Report

    Report Number
    6000002-2008-07281
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    PMA / PMN Number
    K056309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT CORRELATING WITH THE OXIMETRY READINGS, BUT STILL RECEIVED GOOD OPTICAL SIGNALS. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDISAT - CENTRAL VENOUS OXIMETRY CATHETER KIT CENTRAL VENOUS OXIMETRY SET DYG EDWARDS LIFESCIENCES XT358HK 58332683

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other