BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA

    MDR report key: 2013077 · Received March 1, 2011

    Report

    Report Number
    1220063-2011-00004
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 31, 2011
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATION THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGHER THAN EXPECTED SPO2 READINGS ARE SOMETIMES DISPLAYED ON DELTA MONITORS WITH MASIMO PODS FOR PATIENTS WITH ABOVE-NORMAL BILIRUBIN LEVELS. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS18597 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NO