BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M AF811 MASK

    MDR report key: 18472273 · Received January 8, 2024

    Report

    Report Number
    2518422-2024-01291
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    December 9, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    30606959034359
    PMA / PMN Number
    K073600
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INFORMATION IN COMPLAINT DETAILS: 1063052 C-PAP NASAL MASK (MEDIUM) ¿ REF (B)(4) AND LOT: 191114 SAME PATIENT, ADDITIONAL DEVICE (MASK) CAPTURED IN COMPLAINT RA (B)(4) H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION N REFERENCE TO A AF811 ORO-NASAL MASK. THE PATIENT ALLEGES WHILE IN USE, THE SAFETY VALVE CLOSES ON A SPONTANEOUS BREATH ON THE NASAL MASK. AT THE TIME THIS ISSUE OCCURRED, USE OF THE DEVICE WAS STOPPED AND RESTARTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. UPDATED: SECTION B: ADVERSE EVENT/PRODUCT PROBLEM: CHANGED TO "PRODUCT PROBLEM". SECTION H: TYPE OF REPORTED COMPLAINT: CHANGED TO "PRODUCT PROBLEM". SECTION H: HEALTH IMPACT GRID: CHANGED TO "NO HEALTH CONSEQUENCES OR IMPACT".

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A AF811 ORO-NASAL MASK. THE PATIENT ALLEGES WHILE IN USE, THE SAFETY VALVE CLOSES ON A SPONTANEOUS BREATH ON THE NASAL MASK. AT THE TIME THIS ISSUE OCCURRED, USE OF THE DEVICE WAS STOPPED AND RESTARTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605675 M AF811 MASK FULL FACE MASK BZD RESPIRONICS, INC. 1063052 191114 30606959034359

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention