BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSINO AMSURE

    MDR report key: 23335479 · Received October 20, 2025

    Report

    Report Number
    1417519-2024-00010
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Manufacturer
    AMSINO HEALTHCARE (USA) INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPECIFIC LOT NUMBER INVOLVED IN THIS EVENT IS NOT KNOWN. HOWEVER, PURCHASING INFORMATION SUPPLIED BY THE INTERMEDIARY NARROWED THE SCOPE TO J583 (EXP. DATE 18-MAY-2027) OR J582 (EXP. DATE 17-MAY-2024), AS THESE WERE THE LOTS PURCHASED BY THE END USER FROM THE INTERMEDIARY. 1. J852 MANUFACTURE DATE: 17-MAY-2023, 2. J853 MANUFACTURE DATE: 18-MAY-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 06 MAY 2024 TO AMSINO VIA EMAIL THAT: WE HAVE RECEIVED FROM ONE OF OUR HOSPITALS COMPLAINT REGARDING AS0552E. WHEN INCREASING THE FLOW ABOVE 6L PER MINUTE THERE IS A LOUD NOISE OF PRESSURE. DO YOU KNOW WHAT CAN BE THE REASON? IT HAPPENED IN MORE THAN ONE BOTTLE, IN DIFFERENT DEPARTMENTS IN THE HOSPITAL, AND THIS IS FIRST TO US. SUBSEQUENTLY, FURTHER INFORMATION WAS GATHERED ON 03 JUN 2024 TO AMSINO VIA EMAIL THAT: 1. THIS HAPPENED IN AT LEAST 10 BOTTLES, AND THESE ARE ONLY THE CASES REPORTED TO US. OF THESE, I HAVE 3 TO SEND YOU FOR EXAMINATION, THE ONES THE CLIENT KEPT FOR US. THE LOT NUMBERS ARE: J582 AND J583. 2. IT WAS REPORTED TO US ONLY FROM (B)(6) HOSPITAL LOCATED IN THE NORTH OF THE COUNTRY. THE DEPARTMENTS ARE INTERNAL MEDICINE AND A SURGICAL WARD. 3. MAINLY A DELAY IN PROVIDING ADEQUATE TREATMENT TO THE PATIENT, BECAUSE THE STAFF OPENED SEVERAL BOTTLES TO OVERCOME THE PROBLEM OF THE LOUD ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2860285 AMSINO AMSURE Nebulizer (direct patient interface) CAF AMSINO HEALTHCARE (USA) INC. AS0552E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other