BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTOA-FLEX

    MDR report key: 14337193 · Received May 9, 2022

    Report

    Report Number
    2518422-2022-18187
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 23, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005891
    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 2518422-2022-18187-1 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 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 SOUNDABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED TO EXPERIENCE NON-SMALL CELL CANCER. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE REPORTED EVENT OF NON-SMALL CELL CANCER 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. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION AND AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. SECTIONS 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 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON OCT 23, 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 PATIENT WAS DIAGNOSED WITH NON-SMALL CELL LUNG CANCER 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 THE INTERNAL AND EXTERNAL INVESTIGATION MANUFACTURER OBSERVED A DUST LIKE CONTAMINATE ON THE EXTERIOR AND INTERIOR OF THE HUMIDIFIER FLIP LID, EXTERIOR AND INTERIOR OF THE ISO PORT (INTERNATIONAL ORGANIZATION OF STANDARDIZATION), FLIP LID SEAL, DRY BOX, DRY BOX SEAL, DRY BOX INLET SEAL, HUMIDIFIER TOP HOUSING, EXTERIOR AND INTERIOR OF THE HUMIDIFIER BOTTOM ENCLOSURE, HEATER PLATE, EXTERIOR AND INTERIOR OF THE LOWER BASE, EXTERIOR AND INTERIOR OF THE OF THE TOP ENCLOSURE, PCA (PRINTED CIRCUIT ASSEMBLY), FLOW MANIFOLD, EXTERIOR AND INTERIOR OF THE BLOWER HOUSING, RIGHT SIDE ASSEMBLY, HUMIDIFIER CABLE, BLOWER, AIR INLET SEAL, AND THE EXTERIOR AND INTERIOR OF THE BOTTOM ENCLOSURE. HAIRLIKE FIBERS ON THE FLIP LID SEAL, HEATER PLATE, INTERIOR OF THE LOWER BASE, PCA, INTERIOR OF THE UPPER BLOWER HOUSING, PHILIPS FOAM FILTER, AND INTERIOR OF THE BOTTOM ENCLOSURE. A DARK UNKNOWN CONTAMINATE ON THE EXTERIOR OF THE SIDE PANEL. A YELLOWISH TINT ON THE DRY BOX SEAL, DRY BOX INLET SEAL, AND THE AIR INLET SEAL. THE DEVICE WAS MISSING THE UI KNOB (USER INTERFACE), SD CARD, AND SD CARD COVER. LIQUID SPOTS CONSISTENT WITH LIQUID INGRESS ON THE EXTERIOR AND INTERIOR OF THE ISO PORT, INTERIOR OF THE FLIP LID, AND THE INTERIOR OF THE BOTTOM ENCLOSURE. A WHITE DUST LIKE SUBSTANCE CONSISTENT WITH MINERAL DEPOSITS ON THE EXTERIOR AND INTERIOR OF THE ISO PORT, INTERIOR OF THE FLIP LID, AND THE INTERIOR OF THE HUMIDIFIER BOTTOM ENCLOSURE. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THIS DEVICE.. THE MANUFACTURER WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND 9 ERROR CODES. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND VERIFIED AIRFLOW. THE MANUFACTURER CONCLUDES, THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN AND OBSERVED DUST LIKE CONTAMINATION AND WAS NOT ABLE TO CONFIRM THE COMPLAINT OR ADDRESS THE SYMPTOMS SPECIFIED. SECTIONS D8, D9, H2, H3 AND H6 HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED BEING DIAGNOSED WITH NON SMALL CELL LUNG CANCER WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    1460153 REMSTAR AUTOA-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560HS 00606959005891

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other