BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEA

    MDR report key: 15173512 · Received August 5, 2022

    Report

    Report Number
    9611500-2022-00198
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    July 26, 2022
    Report Date
    August 15, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT, DATED ON 5TH AUGUST 2022, WAS SENT IN RESPONSE TO THE INFORMATION RECEIVED ABOUT AN EVENT INVOLVING A LINEA VERTICA, PRODUCT SERIAL NUMBER (B)(6). AS THIS PRODUCT IS DISTRIBUTED AND INSTALLED BY DRÄGER, BUT DRÄGER IS NOT THE LEGAL MANUFACTURER. THE INVESTIGATION WAS STARTED AND AN INITIAL ASSESSMENT REGARDING THE REPORTABILITY WAS PERFORMED. THE EXAMINATION OF THE AFFECTED DEVICE AND SIMILAR DEVICES AT THE CUSTOMER SITE REVILED, THAT THE LOCKING SCREW IN THE UPPER BRACKETS WERE NOT TIGHTENS SUFFICIENTLY AT MULTIPLE SYSTEMS. THE SYSTEM IS DELIVERED READY ASSEMBLED BY THE COMPANY VISION TECHNOLOGY SYSTEMS GMBH. IT IS NOT NECESSARY TO UNSCREW LOCKING SCREWS MENTIONED ABOVE, NEITHER WHEN MOUNTING THE SYSTEM ON THE WALL AT THE CUSTOMER SITE, NOR FOR MOUNTING ACCESSORIES. THIS IS THE REASON FOR THE ASSUMPTION THAT THE REPORTED ISSUE IS DUE TO A PROBLEM IN THE ASSEMBLY OF THE SYSTEM DURING PRODUCTION AT THE SUPPLIER VISION TECHNOLOGY SYSTEMS GMBH RATHER THAN AN INSTALLATION / MOUNTING ISSUE. DRÄGER CONCLUDES THAT THERE IS NO OBLIGATION ANYMORE FOR DRÄGER TO CONSIDER THIS EVENT AS REPORTABLE AS AN INSTALLATION ISSUE (INSTALLATION DONE BY DRÄGER) COULD BE EXCLUDED AND DRÄGER IS NOT THE LEGAL MANUFACTURER OF THE AFFECTED DEVICE. THE CASE WAS THEREFORE FORWARDED TO THE RESPONSIBLE MANUFACTURER VISION TECHNOLOGY SYSTEMS GMBH. THE ASSESSMENT OF THE INCIDENT REGARDING WHETHER A REPORT TO THE COMPETENT AUTHORITIES IS NECESSARY, THE TECHNICAL INVESTIGATION AND THE RISK ASSESSMENT IS THE RESPONSIBILITY OF THE LEGAL MANUFACTURER VISION TECHNOLOGY SYSTEMS GMBH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE VERTICAL TUBE BECAME LOOSE AND FELL OUT OF THE BRACKET ON THE WALL TO THE FLOOR. DUE TO THIS THE CATHETER WAS PULLED OUT OF THE PATIENT. IT IS THEREFORE NECESSARY TO CREATE A NEW ACCESS WHICH MAY REQUIRE THE ADMINISTRATION OF ANESTHETICS. DUE TO THE TORN OUT ACCESSES THE MEDICATION APPLIED WAS TEMPORARILY UNAVAILABLE TO THE PATIENT. IT CAN BE ASSUMED THAT THE PATIENT WAS BLEEDING DUE TO THE WOUNDS CREATED BY THE TORN OUT ACCESSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE VERTICAL TUBE BECAME LOOSE AND FELL OUT OF THE BRACKET ON THE WALL TO THE FLOOR. DUE TO THIS THE CARTHETER WAS PULLED OUT OF THE PATIENT. IT IS THEREFORE NECESSARY TO CREATE A NEW ACCESS WHICH MAY REQUIRE THE ADMINISTRATION OF ANESTHETICS. DUE TO THE TORN OUT ACCESSES THE MEDICATION APPLIED WAS TEMPORARILY UNAVAILABLE TO THE PATIENT. IT CAN BE ASSUMED THAT THE PATIENT WAS BLEEDING DUE TO THE WOUNDS CREATED BY THE TORN OUT ACCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603051 LINEA MEDICAL GAS AND VACUUM SYSTEMS GCX DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention