BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 11826265 · Received May 14, 2021

    Report

    Report Number
    3000219639-2021-00010
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SALTER LABS
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ISSUE HAS BEEN TIED TO THE DESIGN CHANGE THAT DERIVED FROM A CONTINUOUS IMPROVEMENT PROJECT. THE PROJECT SHIFTED THE PEDIATRIC HANDLE TO CONTAIN 3-BATTERIES RATHER THAN 2-BATTERIES, WHICH WAS MANUFACTURED AFTER FEBRUARY 2020. THIS CHANGE WAS MEANT TO INCREASE SHELF LIFE AND IMPROVE PERFORMANCE. RA: PER THE RISK ANALYSIS FILED (RA-08) THE SEVERITY OF HARM ASSOCIATED WITH THIS COMPLAINT IS CONSIDERED 6-MAJOR WHICH DOES NOT MEET THE RISK THRESHOLD FOR CARB REVIEW (8-SERIOUS).

    Description of Event or Problem · 0

    DURING AN INTUBATION THE RT ATTEMPTED TO ASSEMBLE THE PURPLE DISPOSABLE LARYNGOSCOPE HANDLE AND BLADE FOR THE MD. THREE SEPARATE HANDLES AND BLADES WERE TESTED AND NONE OF THE LIGHTS WERE WORKING. TWO SIZE 1 MILLER BLADES AND ONE SIZE 0 BLADE WERE TESTED. PATIENT WAS BEING MANUALLY VENTILATED WITH A BAG MASK AT THE TIME.

    Additional Manufacturer Narrative · 1

    DURING INTUBATION, THE RT ATTEMPTED TO ASSEMBLE THE PURPLE DISPOSABLE LARYNGOSCOPE HANDLE AND BLADE FOR THE MD. THREE SEPARATE HANDLES AND BLADES WERE TESTED AND NONE OF THE LIGHTS WERE WORKING. TWO SIZE 1 MILLER BLADES AND ONE SIZE 0 BLADE WERE TESTED. PATIENT WAS BEING MANUALLY VENTILATED WITH A BAG MASK AT THE TIME. THE BLADES AND HANDLES WERE DETERMINED TO BE THE ISSUE FOR THE DELAYED INTUBATION IN A CRITICAL SITUATION. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 1

    DURING AN INTUBATION THE RT ATTEMPTED TO ASSEMBLE THE PURPLE DISPOSABLE LARYNGOSCOPE HANDLE AND BLADE FOR THE MD. THREE SEPARATE HANDLES AND BLADES WERE TESTED AND NONE OF THE LIGHTS WERE WORKING. TWO SIZE 1 MILLER BLADES AND ONE SIZE 0 BLADE WERE TESTED. PATIENT WAS BEING MANUALLY VENTILATED WITH A BAG MASK AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725923 SALTER LABS BX20 - PEDIATRIC DISPOSABLE HANDLE 23BATTERY CCW SALTER LABS 2016.C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other