BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMUS

    MDR report key: 2994947 · Received February 27, 2013

    Report

    Report Number
    9611500-2013-00017
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF THE VENTILATOR OR GAS DELIVERY SYSTEM WAS REPORTED OR SUSPECTED BY THE USERS. THE PGM GAS MEASUREMENT SYSTEM WAS TESTED ON SITE BY A DRAGER SERVICE REPRESENTATIVE AND FOUND TO MEET SPECIFICATION. THE PGM LOG WAS DOWNLOADED AND ANALYZED. THE LOG REVEALS NO HINT TO A DEVICE FAILURE. ALL CALIBRATIONS WERE PASSED. IF THE FINAL MANUFACTURER INVESTIGATION SHOULD RESULT IN NEW FINDINGS, THIS WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PRIMUS WAS USED ON A PATIENT ((B)(6)) BETWEEN 12.15 H AND 14.45 H. DURING THIS PERIOD, THE CONDITION OF THE PATIENT DETERIORATED. USERS DID NOT TRUST THE PGM GAS MEASUREMENT IN THIS PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84148 PRIMUS ANESTHESIA WORKPLACE CBK DRAEGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention