BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR

    MDR report key: 12284168 · Received August 5, 2021

    Report

    Report Number
    2518422-2021-02723
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    July 26, 2021
    Report Date
    September 14, 2021
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    UDI-DI
    00606959030725
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058. CORRECTED DATA: G4 PMA/510(K) NUMBER: PREVIOUSLY REPORTED AS K113068 ; UPDATED TO K091319.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND THE PATIENT WAS DIAGNOSED WITH LUNG CANCER AND UVEITIS. THE DETAILS OF THE PATIENT'S REQUIRED MEDICAL INTERVENTION ARE UNKNOWN. 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
    1176151 REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC FR565S 00606959030725

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HUMIDIFIER - SN (B)(6)