BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 18280477 · Received December 7, 2023

    Report

    Report Number
    2518422-2023-34040
    Event Type
    Death
    Date Received
    December 7, 2023
    Date of Event
    November 14, 2023
    Report Date
    July 17, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030497
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY 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 PREVIOUSLY RECEIVED A VOLUNTARY MEDWATCH REPORT (MW5147942). THE PATIENT IS ALLEGING A DIAGNOSIS OF A NON-CURABLE FORM OF LUNG CANCER AFTER USING THE DEVICE FOR AT LEAST 12 YEARS AND DESPITE QUITTING SMOKING ALMOST 40 YEARS BEFORE THE DIAGNOSIS. THE PATIENT WAS INFORMED THAT HIS LIFE EXPECTANCY WAS 13 MONTHS. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE PATIENT WAS 74 YEARS OLD AT THE TIME OF HIS DEATH.PATIENT OUTCOME CODE GRID HAS BEEN UPDATED AND CORRECTED.

    Additional Manufacturer Narrative · 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 A VOLUNTARY MEDWATCH REPORT (MW5147942). THE PATIENT IS ALLEGING A DIAGNOSIS OF A NON-CURABLE FORM OF LUNG CANCER AFTER USING THE DEVICE FOR AT LEAST 12 YEARS AND DESPITE QUITTING SMOKING ALMOST 40 YEARS BEFORE THE DIAGNOSIS. THE PATIENT WAS INFORMED THAT HIS LIFE EXPECTANCY WAS 13 MONTHS. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE PATIENT WAS 74 YEARS OLD AT THE TIME OF HIS DEATH. THERE IS NO CUSTOMER INFORMATION HENCE WE CANNOT REACH OUT TO THE CUSTOMER 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 BOX A: PATIENT IDENTIFIER IS UPDATED. IN BOX H: EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, CONCLUSION CODE GRID HAS BEEN UPDATED.

    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 A VOLUNTARY MEDWATCH REPORT (MW5147942). THE PATIENT IS ALLEGING A DIAGNOSIS OF A NON-CURABLE FORM OF LUNG CANCER AFTER USING THE DEVICE FOR AT LEAST 12 YEARS AND DESPITE QUITTING SMOKING ALMOST 40 YEARS BEFORE THE DIAGNOSIS. THE PATIENT WAS INFORMED THAT HIS LIFE EXPECTANCY WAS 13 MONTHS. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE PATIENT WAS 74 YEARS OLD AT THE TIME OF HIS DEATH. 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
    876413 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 560P 00606959030497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death