BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY DOCKING STATION

    MDR report key: 1062297 · Received June 18, 2008

    Report

    Report Number
    1220063-2008-00019
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 18, 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 EVAL 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 SUPPLIER CORRECTIVE ACTION AND INITIATED A FIELD CORRECTION. THE DEVICE IDENTIFIED IN THIS INCIDENT FALLS IN THE RANGE OF THE POTENTIALLY DEFECTIVE DEVICES OF THE FIELD CORRECTION NUMBER: (B) (4).

    Description of Event or Problem · 1

    WHEN TAKING THE PT MONITOR INFINITY DELTA FROM THE INFINITY DOCKING STATION (IDS) IT FELL DOWN. THE TOP COVER OF THE IDS SEPARATED FROM THE BOTTOM (THE NUTS WERE TORN OFF). NO PERSONS WERE INJURED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY DOCKING STATION PATIENT MONITOR DOCKING STATION MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) 5206110 5466271863

    Patients

    Seq Age Sex Outcome Treatment
    1