BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14105186 · Received April 13, 2022

    Report

    Report Number
    2518422-2022-13218
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    March 14, 2022
    Report Date
    June 22, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    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 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 CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED TO STROKE. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE REPORTED STROKE,AND CHEMO 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. 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 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-13218-3 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 WAS PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGES TO HAVE "HAD A STROKE." THERE IS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. AN INTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER. THE MANUFACTURER FOUND EVIDENCE OF SOUND ABATEMENT FOAM IN THE BLOWER BOX AND IN THE ISO PORT, SLIGHT WHITE COLORED DUST LIKE CONTAMINATION AT THE AIR INLET AND LIQUID INGRESS ON THE BLOWER HOUSING. THE MANUFACTURER FOUND EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND ERROR E-72. THE MANUFACTURER CONCLUDES THERE WAS EVIDENCE OF MULTIPLE CONTAMINATION FROM THE DEVICE. THE MANUFACTURER CONFIRMED THERE WAS EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN. AFTER FURTHER REVIEW, THE MANUFACTURER CONFIRMED THAT THE PREVIOUSLY SUBMITTED REPORT WAS INCORRECTLY FILED AS ADVERSE EVENT WHICH SHOULD HAVE BEEN FILED AS PRODUCT PROBLEM ONLY. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGES TO HAVE "HAD A STROKE." THERE IS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786716 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other