BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 19632097 · Received June 28, 2024

    Report

    Report Number
    2518422-2024-40496
    Event Type
    Death
    Date Received
    June 28, 2024
    Date of Event
    October 18, 2023
    Report Date
    September 10, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A REMSTAR AUTO A-FLEX DEVICE. THE PATIENT HAS ALLEGEDLY PASSED AWAY. NO MEDICAL INTERVENTION WAS REPORTED BY THE PATIENT. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED. IN THIS REPORT BOX H: EVAL METHOD CODE, EVAL RESULTS CODE AND CONCLUSION CODE IS UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 18, 2025, AND H11 SHOULD BE REPORTED AS THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A REM STAR AUTO A-FLEX DEVICE. THE PATIENT HAS ALLEGEDLY PASSED AWAY. NO MEDICAL INTERVENTION WAS REPORTED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS WAS NOT OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE FIVE ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE NO VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED. EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT AND CONCLUSION CODE GRID WERE UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A REMSTAR AUTO A-FLEX DEVICE. THE PATIENT HAS ALLEGEDLY PASSED AWAY. NO MEDICAL INTERVENTION WAS REPORTED BY THE PATIENT. 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
    820082 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS550HS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death