BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 2032671 · Received March 24, 2011

    Report

    Report Number
    1220063-2011-00010
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Report Date
    December 22, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS COMPLAINT WAS RECEIVED, IT WAS DEEMED NOT REPORTABLE BECAUSE THE MONITOR WILL AUDIBLY ALARM IN THE EVENT OF A SHUT-DOWN TO ALERT THE USER SO THAT THEY MAY TAKE THE APPROPRIATE ACTIONS. HOWEVER, DRAEGER WAS MADE AWARE OF A USER FACILITY REPORT (UFR) AND AFTER FURTHER CONSIDERATION, DRAEGER IS REPORTING THIS EVENT. DRAEGER IS STILL INVESTIGATION THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DELTA MONITOR ALARMED, SHUT DOWN, AND SUBSEQUENTLY WOULD NOT COMPLETE THE POWER ON SEQUENCE TO RESTORE PT MONITORING. THERE WAS NO PT 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 78 YR NO