BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 12097383 · Received June 30, 2021

    Report

    Report Number
    3000219639-2021-00017
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 15, 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

    COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED FOR THE LAST 24 MONTHS. NO SIMILAR COMPLAINTS HAVE BEEN FOUND AND THIS ISSUE DOES NOT APPEAR TO BE TRENDING. HOWEVER, THERE WAS ONE SIMILAR COMPLAINT FOR THE PART NUMBER I-PFTVVC-70. THE INVESTIGATION REPORT PROVIDED BY WELL LEAD (ATTACHED BELOW IN THE ACTIVITY LOG) EXPLAINS WHY THIS ISSUE MAY BE RELATED TO USER ERROR. THIS ISSUE THEREFORE DOES NOT APPEAR TO BE TRENDING, BUT WILL CONTINUE TO BE MONITORED. FORMAL INVESTIGATION AND CUSTOMER FOLLOW UP WERE PERFORMED BY WELL LEAD. PLEASE SEE THE ATTACHED INVESTIGATION REPORT FOR FURTHER DETAILS. 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

    THE USAGE TIME IS UNKNOWN. INFLATION TUBING SEEMS TO HAVE COME OFF THE ROOT DURING USE ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILED WHILE IN PATIENT USE WHICH WOULD CAUSE A DELAY IN TREATMENT AND THE PATIENT TO BE REINTUBATED. THEY CANNOT LEAVE AN ENDOTRACHEAL TUBE IN PLACE IF THEY CANNOT KEEP THE CUFF INFLATED. 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 NOT BEEN MET.

    Description of Event or Problem · 1

    THE USAGE TIME IS UNKNOWN. INFLATION TUBING SEEMS TO HAVE COME OFF THE ROOT DURING USE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993878 SALTER LABS ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFST) BTR SALTER LABS I-PFST-70 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other