BEUDAMED
    FDA Adverse Event Other Summary report: N

    D-VAPOR

    MDR report key: 1872239 · Received August 27, 2010

    Report

    Report Number
    9611500-2010-00035
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 27, 2010
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CAD
    PMA / PMN Number
    K042276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS REPORT WAS FILED IN RESPONSE TO VOLUNTARY UFR, ESPECIALLY WITH RESPECT TO THE UF STATEMENT/GUESS THAT THE AFFECTED POWER CORD OF THE DRAEGER D-VAPOR IS SUBJECT OF AN ONGOING PRODUCT RECALL OF POWER CORDS (MADE BY ELECTRI-CORD). THE AFFECTED DEVICE (INCL. POWER CORD) WAS REQUESTED FOR INVESTIGATION AT MFR SITE AND WAS RECEIVED (B)(4) 2010. IT CAN BE STATED THAT THE POWER CORD IN QUESTION IS NOT SUBJECT TO A PRODUCT RECALL OF POWER CORDS (MADE BY ELECTRI-CORD). THE ELECTRICAL PLUG IDENTIFIED IN THIS CASE WAS MFG BY FELLER LLC. THE POWER CORD WAS SUBMITTED TO FELLER LLC FOR FURTHER INVESTIGATION; RESULTS ARE PENDING. DRAEGER MUST EMPHASIZE THAT THIS IS THE FIRST REPORTED CASE ON A BURNT POWER PLUG OF THIS TYPE. THE INVESTIGATION IS ONGOING; RESULTS WILL BE REPORTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    MFR RECEIVED A VOLUNTARY MEDWATCH REPORT FROM A USER FACILITY ((B)(6)) REGARDING A DRAEGER DESFLURANE VAPORIZER. BY THIS VOLUNTARY UFR IT IS REPORTED THAT THE ANESTHESIOLOGIST NOTICED THAT THE VAPORIZER DID NOT POWER ON. IT WAS FOUND THAT THE NEUTRAL PIN OF THE ELECTRICAL POWER PLUG WAS BURNED OFF AND WAS STUCK IN THE POWER RECEPTACLE. IT WAS FURTHER STATED IN THIS VOLUNTARY UFR THAT THE DEVICE IN QUESTION HAD AN ELECTRI-CORD POWER CORD, WHICH IS SUBJECT OF OTHER MFR'S RECALL, BUT NOT BY DRAEGER AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-VAPOR VAPORIZER, ANESTHETIC AGENT CAD DRAEGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other