BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY

    MDR report key: 1082791 · Received July 23, 2008

    Report

    Report Number
    1220063-2008-00024
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2007
    Report Date
    July 23, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    Removal / Correction Number
    2517967-11/16/06-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INITIAL EVAL HAS CONFIRMED THAT THE TOP COVER OF THE DEVICE ACTUALLY SEPARATED FROM THE BASE AS REPORTED. THIS IS A KNOWN SUPPLIER ISSUE AND WE HAVE IMPLEMENTED A SUPPLIER CORRECTIVE ACTION AND INITIATED A FIELD CORRECTION. THE DEVICE IDENTIFIED IN THIS INCIDENT DOES NOT FALL IN THE RANGE OF THE POTENTIALLY DEFECTIVE DEVICES OF THE FIELD CORRECTION NUMBER: 2517967-11/16/06-001-C. WE ARE CONSIDERING THIS AN ISOLATED INCIDENT DUE TO THE AGE OF THE DEVICE. HOWEVER, WE WILL CONTINUE MONITORING THE COMPLAINTS AND IF ADD'L COMPLAINTS OF THIS NATURE ARE REPORTED FOR THE DEVICES PRIOR TO THE RECALL TIMELINE, WE WILL REVISIT THE SCOPE OF THE RECALL AND TAKE APPROPRIATE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COVER OF AN INFINITY DOCKING STATION (IDS), MFG IN 2003, DETACHED FROM ITS BASE. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY PATIENT MONITOR DOCKING STATION MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) 5206110 5463559559

    Patients

    Seq Age Sex Outcome Treatment
    1