BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW-I C20

    MDR report key: 6109172 · Received November 17, 2016

    Report

    Report Number
    8010042-2016-00517
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 20, 2016
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K133958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2016 10:29 AM (GMT-5:00) ADDED BY (B)(6)): THE INVESTIGATION CONSISTS OF A RECEIVED DEVICE LOGS EVALUATION AND INFORMATION FROM THE HOSPITAL. NO FIELD SERVICE ENGINEER HAS BEEN ON-SITE, SINCE THE CUSTOMER IS FULLY TRAINED IN MAINTAINING THE ANESTHESIA SYSTEM. THE BIOMEDICAL ENGINEER AT THE CUSTOMER SITE DOWNLOADED THE DEVICE LOGS AND SENT THEM FOR EVALUATION. THE ANESTHESIA WORKSTATION IS REPORTED TO BE BACK IN USE WITHOUT FURTHER ISSUES. THE DEVICE LOGS WERE RECEIVED AND AFTER OUR LOG EVALUATION, WE CAN CONCLUDE THAT THE USER DID NOT ACTIVATE ANESTHETIC AGENT FOR THE FIRST 21 MINUTES OF THE REPORTED CASE. THERE ARE NO TECHNICAL ERROR CODES TO INDICATE A DEVICE MALFUNCTION, AND SUCCESSFUL SYSTEM CHECK OUT TESTS WERE PERFORMED BOTH PRIOR TO, AND AFTER, THE EVENT. OUR CONCLUSION INTO THIS MATTER IS, THAT AFTER HAVING SEDATED THE PATIENT INTRAVENOUSLY BEFORE THE SURGERY, THE USER DID NOT ACTIVATE THE ANESTHETIC AGENT ON THE ANESTHESIA WORKSTATION DURING THE FIRST 21 MINUTES OF THE SURGERY. THIS LED TO AN INCREASED LEVEL OF PATIENT AWARENESS. THIS EVENT IS TO BE CONSIDERED AS A USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SURGERY (GENERAL ANESTHESIA)WITH THE ANESTHESIA WORKSTATION, THE PATIENT REPORTED AWARENESS. THE PATIENT REPORTED HEARING MUSIC AND TALK. THERE WAS NO REPORT OF PATIENT EXPERIENCING PAIN OR HARM. THERE WAS NO PERMANENT PATIENT INJURY REPORTED. MANUFACTURER REFERENCE # : (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760793 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other