BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILTERS

    MDR report key: 18587055 · Received January 25, 2024

    Report

    Report Number
    MW5150714
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Report Date
    January 24, 2024
    Manufacturer
    UNK
    Product Code
    JRL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE SEEN WITH MY OWN EYES FOUR DIFFERENT BRAND CPAP FILTERS. NEW OUT OF SEALED PACKAGE. WHEN TAPPED OR FLICKED. HUNDREDS OF PARTICLES ERUPT FROM FILTERS AND SWARM AROUND FILTER. THIS FILTER IS WHAT AIR IS PUMPED THROUGH, THEN INJECTED INTO PATIENT LUNGS AT HIGH VELOCITY, WHERE PARTICLES BECOME EMBEDDED IN PATIENT LUNG TISSUE. REFERENCE REPORTS: MW5150712, MW5150713, MW5150715.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649266 FILTERS UNIT, FILTER, MEMBRANE JRL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP)