BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUBRUTE

    MDR report key: 20325443 · Received September 27, 2024

    Report

    Report Number
    3000219639-2024-00074
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 27, 2024
    Manufacturer
    SALTER LABS
    Product Code
    CCW
    UDI-DI
    00607411964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 27 SEPT 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 27 SEPT 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY THE COMPLAINT OF "LIGHT STOPPED WORKING" REGARDING PART 2017.C WAS NOT CONFIRMED. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. PER WI-20020-C1 REV 2, SEC 15.6: FOR PRODUCTS IN WHICH AIRLIFE DISTRIBUTES, BUT IS NOT THE MANUFACTURER, COMPLAINTS WILL BE CAPTURED AND DISSEMINATED TO THE MANUFACTURER BUT DOES NOT REQUIRE INVESTIGATION, REPORTABILITY ASSESSMENT, CAPA ESCALATION, RISK ANALYSIS, AS THIS IS THE RESPONSIBILITY OF THE LEGAL MANUFACTURER AND WILL BE CLOSED. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Description of Event or Problem · 0

    LARYNGOSCOPE HANDLE AND BLADE LIGHT STOPPED WORKING UPON ATTEMPTING TO INTUBATE.

    Description of Event or Problem · 0

    LARYNGOSCOPE HANDLE AND BLADE LIGHT STOPPED WORKING UPON ATTEMPTING TO INTUBATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831674 INTUBRUTE STUBBY SINGLE USE DISPOSABLE LARYNGOSCOPE HANDLE CCW SALTER LABS 2017.C 29B 00607411964435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other