BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER AIRE ELITE

    MDR report key: 19638837 · Received June 28, 2024

    Report

    Report Number
    3000219639-2024-00058
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 28, 2024
    Manufacturer
    SALTER LABS
    Product Code
    CAF
    UDI-DI
    00607411005046
    PMA / PMN Number
    K962879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 28 JUNE 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 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 COMPLAINT REPORTED "STOPPED WORKING." THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. BASED ON THE COMPLAINT REPORT NO PATIENT WAS AFFECTED, THE ISSUE WAS NOTED AT HOME. THERE WERE NO PHOTO IMAGES OR VIDEOS OF THE REPORTED ISSUE; THEREFORE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. THE PRODUCT IS UNDER WARRANTY; THEREFORE, THE CUSTOMER IS REQUESTING A WARRANTY REPLACEMENT. THE WARRANTY REPLACEMENT ORDER NUMBERS ARE (B)(4). A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THIS IS THE (B)(4) COMPLAINT REPORTED FOR PART NUMBER SO-1774BE. THIS IS THE (B)(4) COMPLAINT REPORTED FOR PART NUMBER SO-1408GN FOR "NON-FUNCTIONAL." THERE WERE (B)(4) COMPLAINTS REPORTED FOR PART NUMBER SO-1408GN DURING THE SAME TIMEFRAME FOR OTHER FAILURE MODES. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Description of Event or Problem · 0

    STOPPED WORKING.

    Description of Event or Problem · 0

    STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214937 SALTER AIRE ELITE SALTER AIRE ELITE COMPRESSOR WITH NEBULIZER CAF SALTER LABS SO-1408GN N/A 00607411005046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other