BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 1813102 · Received August 18, 2010

    Report

    Report Number
    1220063-2010-00033
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 4, 2009
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 IS INITIATING A CORRECTIVE ACTION TO ADDRESS THIS PROBLEM. NO PATIENT DEATHS OR INJURIES HAVE BEEN REPORTED AS A RESULT OF THIS CONDITION.

    Description of Event or Problem · 1

    REFERENCE: MDR 1220063-2009-00045. 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. (B)(4). IT WAS REPORTED THAT THE DEVICE SWITCHED FROM DISCHARGE MODE SPORADICALLY AND ON ITS OWN TO ACTIVE MODE. A DEVICE ALSO SWITCHED FROM ACTIVE MODE TO DISCHARGE MODE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO