BEUDAMED
    FDA Adverse Event Death Summary report: N

    REM AUTO A-FLEX

    MDR report key: 23939497 · Received January 1, 2026

    Report

    Report Number
    2518422-2026-000001
    Event Type
    Death
    Date Received
    January 1, 2026
    Date of Event
    April 1, 2021
    Report Date
    March 2, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT, THE ADVERSE EVENT/PRODUCT PROBLEM FIELD IN BOX B WAS INCORRECTLY MARKED AS ¿BOTH.¿ THIS HAS BEEN CORRECTED TO ¿ADVERSE EVENT,¿ AND THE OUTCOME ATTRIBUTED TO AE HAS BEEN UPDATED TO ¿DEATH.¿ IN THE PREVIOUS REPORT, THE ADDITIONAL NARRATIVE WAS CAPTURED INCORRECTLY, AND IT HAS BEEN CORRECTED AS FOLLOWS: THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO A REM AUTO A-FLEX WITH AN ALLEGATION OF PATIENT PASSED AWAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT, THE PATIENT OUTCOME CODE IN BOX H WAS CAPTURED INCORRECTLY. IT HAS BEEN CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUS REPORT, THE DESCRIBE EVENT OR PROBLEM IN BOX B WAS CAPTURED INCORRECTLY. THE CORRECTED VERBIAGE SHOULD BE REPORTED AS STATED BELOW. THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO A REM AUTO A-FLEX WITH AN ALLEGATION OF PATIENT PASSED AWAY. THERE IS NO MEDICAL INTERVENTION WAS SPECIFIED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. IN THE PREVIOUS REPORT, THE INFORMATION IN BOX H¿DEVICE PROBLEM CODE GRID, REMEDIAL ACTION INITIATED, AND RECALL (Z) NUMBER¿WAS CAPTURED INCORRECTLY. THE DEVICE PROBLEM CODE GRID HAS BEEN CORRECTED IN THIS REPORT. REMEDIAL ACTION INITIATED AND RECALL (Z) NUMBER HAVE BEEN CORRECTED TO BLANK.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT PATIENT PASSED RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. 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
    108098 REM AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. RIN561S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death