BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMUS

    MDR report key: 1692442 · Received May 7, 2010

    Report

    Report Number
    9611500-2010-00022
    Event Type
    Other
    Date Received
    May 7, 2010
    Date of Event
    April 29, 2010
    Report Date
    May 7, 2010
    Manufacturer
    DRAGER MEDICAL AG & CO. KG
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN ON-SITE MEETING WITH HOSP REP (INCL. WITNESSES OF THE EVENT) AND DRAGER SPECIALISTS - WHILE DISCUSSING THE EVENT AND COMPARING WITH DATA OF THE DEVICE INTERNAL LOG-FILE - IT WAS CONCLUDED THAT THE DEVICE IN QUESTION (PRIMUS (B)(4)) WAS IN STANDBY MODE AT THE TIME OF THE EVENT. NO EXPLANATION COULD BE FOUND WHY, BUT THE CLINICAL STAFF EXPLAINED THAT THEY WERE VERY CONCENTRATED ON OTHER THINGS. NO INDICATION FOR A TECHNICAL FAILURE OF THE DEVICE COULD BE FOUND. TO SWITCH THE DEVICE INTO STANDBY, A DEFINED HANDLING SEQUENCE IS NECESSARY TO RULE OUT THE UNINTENDED SWITCH TO STANDBY (DESCRIBED IN THE INSTRUCTION FOR USE). FINALLY NO INDICATION FOR A TECHNICAL FAILURE OR A MISSING/MISLEADING INSTRUCTION OF THE DEVICE COULD BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANESTHESIA, THE PT DESATURATED AND THE STAFF STARTED VENTILATION WITH A RUBENS BALLOON. THE PT CAME INTO CRITICAL SITUATION. AFTER THE SURGERY, THE PT WAS TRANSPORTED TO ICU IN ANOTHER HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS ANAESTHESIA DEVICE BSZ DRAGER MEDICAL AG & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention