BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 1915366 · Received November 17, 2010

    Report

    Report Number
    1220063-2010-00085
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    DRAEGER 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
    UK
    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 RECALL ON (B)(4) 2010 TO ADDRESS THIS PROBLEM. NO PATIENT DEATHS OR INJURIES HAVE BEEN REPORTED AS A RESULT OF THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RANDOMLY CAME OUT OF DISCHARGE STATE AND THAT BUTTONS ARE INOPERATIVE APART FROM THE POWER BUTTON. THERE WAS NO PATIENT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. (IT/M) MS18597 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO