BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 11987389 · Received June 11, 2021

    Report

    Report Number
    3000219639-2021-00014
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 30, 2021
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION AS WELL AS ALL CUSTOMER FOLLOW UP WAS PERFORMED BY WELLLEAD. MORE DETAIL CAN BE FOUND WITHIN THE ATTACHED FILES OF THE ACTIVITY LOG. RA: THIS FAILURE MODE (R12) IS IDENTIFIED ON THE RISK ANALYSIS FILE (RA-47). THE SEVERITY OF HARM FOR THIS FAILURE MODE IS CONSIDERED A MAJOR (6) RISK AND DOES NOT MEET THE THRESHOLD FOR CARB REVIEW (8).

    Description of Event or Problem · 0

    A FEW HOURS AFTER THE START OF USE, THE INFLATION TUBE CAME OFF AND THE PILOT BALLOON WAS DEFLATED. THERE WAS NO PROBLEM DURING THE LEAK TEST, AND IT SEEMS THAT S/HE NOTICED WHEN S/HE EXTUBATED THE TRACHEAL TUBE BECAUSE THE ALARM SOUNDED FREQUENTLY AFTER MOVING TO THE ICU AFTER THE OPERATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILED WHILE IN PATIENT USE WHICH WOULD CAUSE A DELAY IN TREATMENT AND THE PATIENT TO BE RE-INTUBATED. THEY CANNOT LEAVE AN ENDOTRACHEAL TUBE IN PLACE IF THEY CANNOT KEEP THE CUFF INFLATED. - THE INCIDENT WOULD REQUIRE AN INTERVENTION; A DEFLATED CUFF COULD CAUSE LOSS OF DELIVERED VOLUME. THE IFU INSTRUCTS USERS TO TEST FOR PROPER INFLATION OF THE CUFF PRIOR TO INTUBATION AND THIS COMMON PRACTICE IN AN INTUBATION PROCEDURE. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 1

    A FEW HOURS AFTER THE START OF USE, THE INFLATION TUBE CAME OFF AND THE PILOT BALLOON WAS DEFLATED. THERE WAS NO PROBLEM DURING THE LEAK TEST, AND IT SEEMS THAT S/HE NOTICED WHEN S/HE EXTUBATED THE TRACHEAL TUBE BECAUSE THE ALARM SOUNDED FREQUENTLY AFTER MOVING TO THE ICU AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885037 SALTER LABS ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM, , BTR SALTER LABS I-PFTVVC-70 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other