BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA XL

    MDR report key: 2240615 · Received April 18, 2007

    Report

    Report Number
    1220063-2007-00006
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    March 23, 2007
    Report Date
    March 28, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K060039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: SERIAL #: (B)(4). WE HAVE REQUESTED THE RETURN OF THE CITED PT MONITOR, SPO2 SENSOR AND ASSOCIATED CABLING USED AT THE TIME OF THE REPORTED INCIDENT. WE WILL EVALUATE THESE ITEMS WHEN RECEIVED. THIS REPORTED INCIDENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTED INCIDENT INVOLVES THE USE OF OUR DELTA PT MONITOR AND OUR SPO2 SENSOR, (B)(4) WHERE IT WAS REPORTED THAT A PEDIATRIC PT SUFFERED AN INJURY AS THE RESULT OF USE. THE PT WAS REPORTED TO HAVE BEEN CONNECTED TO OUR REUSABLE SPO2 SENSOR THAT WAS ATTACHED TO THE TOE AND WAS FOUND TO HAVE SUFFERED SKIN ABRASION AND SLIGHT BURNS TO THE SKIN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI