BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER AIRE ELITE

    MDR report key: 24635498 · Received March 18, 2026

    Report

    Report Number
    3004748541-2026-00050
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Report Date
    May 29, 2026
    Manufacturer
    SALTER LABS
    Product Code
    CCQ
    UDI-DI
    00607411918346
    PMA / PMN Number
    K870027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2026 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS 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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 3004748541-2026-00051 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00052 FOR THE THIRD REPORT. REFER TO 3004748541-2026-00053 FOR THE FOURTH REPORT. REFER TO 3004748541-2026-00054 FOR THE FIFTH REPORT. IT WAS REPORTED, THE AT HOME ASTHMA USER HAS USED THE SALTER AIRE ELITE COMPRESSOR APPROXIMATELY FIVE TIMES, AND EACH TIME THEY TURNED IT ON, THE MOTOR STARTED OUT REGULAR BUT WOULD IMMEDIATELY SLOW DOWN TO WHERE THERE WAS NO MEDICINE COMING OUT. THEY HAD TO TURN IT ON AND OFF ABOUT 15 TIMES BEFORE IT WORKED AT REGULAR SPEED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609432 SALTER AIRE ELITE COMPRESSOR WITH (1) 8900 NEBULIZER CCQ SALTER LABS 8350-8900-7-1 KSN2203-12208 00607411918346

    Patients

    Seq Age Sex Outcome Treatment
    1