BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 23440705 · Received October 31, 2025

    Report

    Report Number
    3004748541-2025-00102
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Report Date
    February 5, 2026
    Manufacturer
    SALTER LABS DE MEXICO DE S.A. DE C.V.
    Product Code
    CAF
    UDI-DI
    00607411890420
    PMA / PMN Number
    K961476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5. AS THERE WAS NO REPORT OF A DELAY IN THERAPY OR HARM OR INJURY TO THE PATIENT AND AS THE INCIDENT WAS DISCOVERED PRIOR TO PATIENT CONTACT, IT HAS BEEN DETERMINED THAT IF THIS INCIDENT WERE TO REOCCUR, AS REPORTED, IT WOULD NOT RESULT IN SERIOUS INJURY OR HARM AND IS THEREFORE, NOT CONSIDERED TO BE A REPORTABLE EVENT. AS THE COMPLAINT WAS DETERMINED TO BE NOT REPORTABLE, NO ADDITIONAL INFORMATION WILL BE SUBMITTED REGARDING THE REPORTED EVENT. ALL INFORMATION REASONABLY KNOWN AS OF 05 FEB 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 (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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; ADDITIONALLY, NO PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE WAS PROVIDED BY THE REPORTER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 31 OCT 2025 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 (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

    IT WAS REPORTED: THE POP OFF VALVE HAD A LOOSE FIT AND DID NOT STAY IN PLACE WHEN IN USE DURING THE NEBULIZER TREATMENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 21OCT2025 REPORTED, THE ISSUE WAS DISCOVERED DURING SETUP OF THE NEBULIZER, IMMEDIATELY PRIOR TO PLACING THE DEVICE ON THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED: THE POP OFF VALVE HAD A LOOSE FIT AND DID NOT STAY IN PLACE WHEN IN USE DURING THE NEBULIZER TREATMENT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299937 SALTER LABS NEBULIZER, NEBU TECH HDN, W/2 ONE-WAY VALVES, MOUTHPIECE CAF SALTER LABS DE MEXICO DE S.A. DE C.V. 8960-7 NOP040918C 00607411890420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown