BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 1882750 · Received October 22, 2010

    Report

    Report Number
    1220063-2010-00065
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    May 26, 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
    FR
    Reporter Occupation
    OTHER

    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 FIELD SAFETY CORRECTION ACTION 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 1220063-2010-00021. PER TELEPHONE COMMUNICATION WITH DRAEGER MEDICAL REGARDING THE SUBMITTAL OF ADDITIONAL MDRS FOR EACH SERIAL NUMBER LISTED ON THE INITIAL MDR SUBMITTED, DRAEGER IS SUBMITTING THIS REPORT. IT WAS REPORTED THAT THERE ARE DEFECTIVE KEYS ON THE FRONT. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO