BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 1879325 · Received October 19, 2010

    Report

    Report Number
    1220063-2010-00060
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 21, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    Z-2283/4-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS INITIATED WITH THE SUPPLIER OF THE SWITCH PANEL. IT WAS DETERMINED THAT THIS CONDITION IS DUE TO A CONTAMINATION PRESENT IN THE FIXED KEY PANEL MATERIAL. A RISK ANALYSIS WAS PERFORMED. DRAEGER MEDICAL INITIATED A RECALL ON 06/04/2010 TO ADDRESS THIS PROBLEM. NO PT DEATHS OR INJURIES HAVE BEEN REPORTED AS A RESULT OF THIS CONDITION.

    Description of Event or Problem · 1

    REFERENCE: MDR 1220063-2010-00054. IT WAS REPORTED THAT THE BEZEL IS CAUSING THE MONITOR TO RANDOMLY PRINT AND SHUT OFF. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO