BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 14306776 · Received May 6, 2022

    Report

    Report Number
    2518422-2022-17386
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 23, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005884
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-17386-1 WITH INCORRECT SECTIONS B1, B2, H1, H6. CORRECTIONS TO PREVIOUS MDR ARE MADE IN THIS REPORT AS FOLLOWS. SECTION B1 WAS CORRECTED TO ADVERSE EVENT AND PRODUCT PROBLEM. (ONLY PRODUCT PROBLEM WAS CHECKED IN PREVIOUS MDR) SECTION B2 WAS CORRECTED TO OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. (PREVIOUSLY IT WAS BLANK) SECTION H1 WAS CHANGED FROM MALFUNCTION TO SERIOUS INJURY. SECTION H6- HEALTH EFFECT - IMPACT CODE WAS UPDATED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. ADDITIONAL INFORMATION WAS RECEIVED AND SECTION B5 SHOULD BE REPORTED AS: 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM AND CAUSED CONGESTIVE HEART FAILURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE REPORTED EVENT OF CAUSEDCONGESTIVE HEART FAILURE AND ITS REPORTED SEVERITY WAS REVIEWED BY THE MANUFACTURE'S CLINICAL EXPERT. THIS EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, THE MANUFACTURE CONCLUDES NO FURTHER ACTION IS NECESSARY. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. SECTION(S) B1, B2, HAS CHANGED RELATED TO THE COMPLAINT CHANGING FROM THE REPORTED ADVERSE EVENT TO A PRODUCT PROBLEM. SECTION H1 HAS CHANGED TO REFLECT A MALFUNCTION. SECTION H6 HEALTH EFFECT- IMPACT CODE, TYPE OF INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON NOV 12, 2024 AND SECTION H11 SHOULD BE REPORTED AS: 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING CONGESTIVE HEART FAILURE THAT ARE RELATED CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING EXTERNAL AND INTERNAL INVESTIGATION, THE MANUFACTURER OBSERVED THAT AN UNKNOWN DUST CONTAMINANT ON THE TOP COVER, PCA, SIDE PANEL, BLOWER CAP, WIRE HARNESS, RIGHT SIDE ASSEMBLY, INSIDE ISO PORT, BLOWER, INLET SEAL, BLOWER OUTLET BELLOW, BLOWER HOUSING, AND BOTTOM ENCLOSURE. MANUFACTURER ALSO OBSERVED BLACK HAIRLIKE CONTAMINANT ON THE TOP COVER, PCA, SIDE PANEL, BLOWER CAP, RIGHT SIDE ASSEMBLY, BLOWER, BLOWER HOUSING, AND BOTTOM ENCLOSURE. MANUFACTURER THAT THE AIR INLET SEAL AND THE BLOWER OUTLET BELLOW WERE DISCOLORED. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS OBSERVED. THE MANUFACTURER WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND NO ERROR CODES. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND VERIFIED AIRFLOW. THE MANUFACTURER CONCLUDES THAT THERE WAS EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE MANUFACTURER CONFIRMED THE PRESENCE OF DUST/DIRT CONTAMINATION IN THE AIRPATH AND UNABLE TO ADDRESS THE PATIENT'S SYMPTOMS. SECTIONS D8, D9, H2, H3 AND H6 HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED CONGESTIVE HEART FAILURE. THE PATIENT DID NOT REPORT TO RECEIVE MEDICAL INTERVENTION. 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
    1077576 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560S 00606959005884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other