BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA XL

    MDR report key: 3060579 · Received March 27, 2013

    Report

    Report Number
    1220063-2013-00015
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL BATTERY DOES NOT HOLD THE SPECIFIED 3 HOURS WHEN DISCONNECTED FROM MAIN POWER. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125168 DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS18596 NA

    Patients

    Seq Age Sex Outcome Treatment
    1