BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 12373147 · Received August 26, 2021

    Report

    Report Number
    3000219639-2021-00021
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 26, 2021
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEFECT CAUSED THE PATIENT TO HAVE A DELAY IN THE INTUBATION PROCEDURE. THERE WAS NO PATIENT INJURY, THIS INCIDENT WILL BE REPORTED. ONE HANDLE HAD VERY DIM LIGHTING AND ANOTHER HAD NO LIGHT AT ALL. THE BLADES AND HANDLES WERE DETERMINED TO BE THE ISSUE FOR THE DELAYED INTUBATION IN A CRITICAL SITUATION. LOW ILLUMINATION MAY DELAY INTUBATION OR INCREASE THE NUMBER OF FAILED ATTEMPTS. STANDARD PRACTICE IS THAT A LARYNGOSCOPE BE CHECKED FOR PROPER ILLUMINATION PRIOR INTUBATION. LIMITED OR NO ILLUMINATION COULD COMPROMISE INTUBATION OR FIRST PASS SUCCESS RATE. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED FOR THE LAST 24 MONTHS. FIVE SIMILAR COMPLAINTS HAVE BEEN REPORTED. SCAR 20-007 IS CURRENTLY OPEN WITH THIS SUPPLIER TO ADDRESS THIS ISSUE. IN THE MEANTIME, HEIGHTENED INSPECTIONS AT EL PASO ARE BEING PERFORMED (LEAD BY JOSH MILLER) TO PREVENT THE ESCAPE OF DEFECTIVE PRODUCT. IF A NONCONFORMING LOT IS IDENTIFIED, AN NCMR IS INITIATED AND A 100% SORT IS PERFORMED. THE SUPPLIER WAS NOTIFIED OF THIS COMPLAINT VIA EMAIL. CUSTOMER FOLLOW UP WAS PERFORMED VIA EMAIL. RA: THIS FAILURE MODE (R8), REDUCED OR NO VISUALIZATION DUE TO A NONFUNCTIONAL LIGHT SOURCE, IS IDENTIFIED ON THE RISK ANALYSIS FILE (RA-44) FOR STERILE SINGLE USE LARYNGOSCOPES. THE SEVERITY OF HARM FOR THIS FAILURE MODE IS CONSIDERED A MODERATE (4) RISK AND DOES NOT MEET THE RISK THRESHOLD FOR CARB REVIEW (8). THERE IS ALREADY A SCAR 20-007 OPEN TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE DEFECT CAUSED THE PATIENT TO HAVE A DELAY IN THE INTUBATION PROCEDURE. THERE WAS NO PATIENT INJURY, THIS INCIDENT WILL BE REPORTED. ONE HANDLE HAD VERY DIM LIGHTING AND ANOTHER HAD NO LIGHT AT ALL. THE BLADES AND HANDLES WERE DETERMINED TO BE THE ISSUE FOR THE DELAYED INTUBATION IN A CRITICAL SITUATION. LOW ILLUMINATION MAY DELAY INTUBATION OR INCREASE THE NUMBER OF FAILED ATTEMPTS. STANDARD PRACTICE IS THAT A LARYNGOSCOPE BE CHECKED FOR PROPER ILLUMINATION PRIOR INTUBATION. LIMITED OR NO ILLUMINATION COULD COMPROMISE INTUBATION OR FIRST PASS SUCCESS RATE. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 0

    WAS ATTEMPTING TO INTUBATE AND THE LIGHT FAILED ON THE LARYNGOSCOPE HANDLE AND BLADE.

    Description of Event or Problem · 0

    WAS ATTEMPTING TO INTUBATE AND THE LIGHT FAILED ON THE LARYNGOSCOPE HANDLE AND BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273012 SALTER LABS BX20 - MILLER 00 DISPOSABLE LED BLADE CCW 1039.C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other