BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 14645411 · Received June 9, 2022

    Report

    Report Number
    3000219639-2022-00025
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 9, 2022
    Manufacturer
    SALTER LABS
    Product Code
    CCW
    UDI-DI
    10607411966405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE POSSIBLE DELAY IN PATIENT INTUBATION AND THERAPY.

    Additional Manufacturer Narrative · 0

    REPORTABLE POSSIBLE DELAY IN PATIENT INTUBATION AND THERAPY. FROM INITIAL EMAIL: PRODUCT REF #404-7438 LOT#S0520-038. GOOGLE SEARCH FOR "404-7438" "LARYNGOSCOPE" FOUND CARNEGIE SURGICAL WEBSITE - WHICH SHOWS INTUBRITE & SZ 3 MILLER BLADE FOR SALE UNDER REF#404-7438. CARNEGIE SURGICAL IS NOT A DISTRIBUTOR FOR SUNMED PRODUCTS, MOST LIKELY THE CUSTOMER HAS CONFUSED OUR PRODUCTS WITH ANOTHER DISTRIBUTOR. SALES TEAM CONFIRMED WE DO NOT SELL PRODUCT TO CS, COMPLAINT DOES NOT FALL IN SCOPE OF COMPLAINT HANDLING. IF CUSTOMER CAN PROVE USE OF A DISTRIBUTOR THAT FALLS WITHIN SCOPE OF COMPLAINT SYSTEM, COMPLAINT WILL BE RE-OPENED. RISK: PRODUCT WAS NOT SOLD BY AN APPROVED SUNMED DISTRIBUTOR, AND MOST LIKELY THROUGH A RESALER OR DIRECT COMPETITOR. THEREFORE SUNMED CANNOT DIRECTLY OR INDIRECTLY CONTROL QUALITY OF THE PRODUCT. NO RISK INVOLVED.

    Description of Event or Problem · 0

    LIGHT IS FLICKERING. POSSIBLE DELAYED INTUBATION.

    Description of Event or Problem · 0

    LIGHT IS FLICKERING. POSSIBLE DELAYED INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171463 SALTER LABS BX10 - COMBO MILLER 3 DISPOSABLE BLADE ..W/ MEDIUM DISPOSABLE HANDLE CCW SALTER LABS 1033.C2015.C S0520-038 10607411966405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other