BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 12097384 · Received June 30, 2021

    Report

    Report Number
    3000219639-2021-00016
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 30, 2021
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ABNORMALITIES IN THE CUFF FOUND AFTER INTUBATION ARE MOST LIKELY CAUSED BY DAMAGE FROM THE PATIENT'S TEETH DURING REMOVAL OF THE DEVICE. THE COMPLAINT DOES NOT MENTION ANY ADVERSE EFFECT ON THE PATIENT, AND IT IS ASSUMED THAT REINTUBATION WAS NOT NECESSARY. THIS TYPE OF COMPLAINT PROVIDES VALUABLE INFORMATION ABOUT THE DURABILITY OF THE PRODUCTS, BUT DOES NOT CONSTITUTE A DEVICE FAILURE. FORMAL INVESTIGATION AND CUSTOMER FOLLOW UP WERE PERFORMED BY WELL LEAD. PLEASE SEE THE ATTACHED INVESTIGATION REPORT. RA: THIS FAILURE MODE (R25), CUFF LOSING PRESSURE DUE TO THE CUFF HAVING A PIN HOLE, IS IDENTIFIED ON THE RISK ANALYSIS FILE (RA-47) FOR ETT. 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

    ACCORDING TO A REPORT FROM THE HOSPITAL, NO ABNORMALITIES WERE FOUND BY CUFF CHECK, BUT S/HE NOTICED THAT PART OF THE CUFF DID NOT INFLATE AFTER INTUBATION.

    Additional Manufacturer Narrative · 1

    THE LEAK OCCURRED AFTER INTUBATION, WHICH MEANS THE ETT WOULD NEED TO BE REPLACED. THEY CANNOT LEAVE AN ENDOTRACHEAL TUBE IN PLACE IF THEY CAN'T 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 THIS INFORMATION THIS IS A REPORTABLE EVENT.

    Description of Event or Problem · 1

    ACCORDING TO A REPORT FROM THE HOSPITAL, NO ABNORMALITIES WERE FOUND BY CUFF CHECK, BUT S/HE NOTICED THAT PART OF THE CUFF DID NOT INFLATE AFTER INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993879 SALTER LABS ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV) BTR SALTER LABS I-PFHV-75 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other