BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 1879299 · Received October 19, 2010

    Report

    Report Number
    1220063-2010-00059
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 21, 2010
    Manufacturer
    GRAGER MEDICAL SYSMTES, 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 (B)(6) 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. DRAEGER REFERENCE NUMBER: (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO