BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS

    MDR report key: 3963769 · Received May 14, 2014

    Report

    Report Number
    9611500-2014-00036
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. WE WILL PROVIDE OUR RESULTS WITHIN A SEPARATE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRIMUS SWITCHED OFF DURING AN ONGOING ANESTHESIA. AFTER SWITCHING IT BACK ON, THE CASE COULD BE COMPLETED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288012 PRIMUS NONE BSZ DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other