BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 19470495 · Received June 5, 2024

    Report

    Report Number
    3000219639-2024-00049
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    April 12, 2024
    Report Date
    October 31, 2024
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    UDI-DI
    00607411700057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 05 JUN 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE INFORMATION RECEIVED REGARDING THIS ISSUE WAS ORIGINALLY REPORTED TO FDA. AIRLIFE'S INVESTIGATION ON THE INCIDENT IS STILL ONGOING AS OF (B)(6) 2024. MEDWATCH REPORT RECEIVED MW5154005 IS ATTACHED. TESTING OF THE RETURNED PRODUCT WAS PERFORMED FOR LEAKAGE, PRESSURE, AND FLOW. NO DEFECT WERE IDENTIFIED DURING THE TESTING. IN THE ABSENCE OF A CONFIRMED DEFECT A ROOT CAUSE CANNOT BE DETERMINED. THE ULTIMATE RISK WAS IDENTIFIED AS LOW WHICH DOES NOT MEET THE THRESHOLD FOR ESCALATION TO CARB.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 05 JUN 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE INFORMATION RECEIVED REGARDING THIS ISSUE WAS ORIGINALLY REPORTED TO FDA. AIRLIFE'S INVESTIGATION ON THE INICIDENT IS STILL ONGOING AS OF 10 JULY 2024. MEDWATCH REPORT RECEIVED MW5154005.

    Description of Event or Problem · 0

    HUMIDIFIER BOTTLE PREVENTING CORRECT FLOW OF OXYGEN (AS SET BY FLOWMETER) TO PATIENT RESULTING IN HYPOXIA. MULTIPLE HUMIDIFIER BOTTLES WITH SAME LOT NUMBER RESULTED IN SAME (REPRODUCIBLE IN SAME LOT). USE OF DIFFERENT LOT NUMBER RESOLVED ISSUE.

    Description of Event or Problem · 0

    HUMIDIFIER BOTTLE PREVENTING CORRECT FLOW OF OXYGEN (AS SET BY FLOWMETER) TO PATIENT RESULTING IN HYPOXIA. MULTIPLE HUMIDIFIER BOTTLES WITH SAME LOT NUMBER RESULTED IN SAME (REPRODUCIBLE IN SAME LOT). USE OF DIFFERENT LOT NUMBER RESOLVED ISSUE. (NARRATIVE FROM MEDWATCH REPORT RECEIVED-MW5154005).

    Description of Event or Problem · 0

    HUMIDIFIER BOTTLE PREVENTING CORRECT FLOW OF OXYGEN (AS SET BY FLOWMETER) TO PATIENT RESULTING IN HYPOXIA. MULTIPLE HUMIDIFIER BOTTLES WITH SAME LOT NUMBER RESULTED IN SAME (REPRODUCIBLE IN SAME LOT). USE OF DIFFERENT LOT NUMBER RESOLVED ISSUE. (NARRATIVE FROM MEDWATCH REPORT RECEIVED-MW5154005)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807524 SALTER LABS HUMIDIFIER, BUBBLE, W/ 6 PSI SAFETY VALVE BTT SALTER LABS 7900-0-25 458420 00607411700057

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other