BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12628990 · Received October 13, 2021

    Report

    Report Number
    2518422-2021-05218
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    August 16, 2021
    Report Date
    August 9, 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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES BLACK DUST COMING OUT OF AIR DUCT, FILTERS TURNING BLACK. THE DEVICE WAS RETURNED AND BLACK CONTAMINANTS IN AIRPATH, BLOWER, BLOWER BOX OBSERVED DURING DEVICE EVALUATION. THERE WAS NO ALLEGATION OF HARM OR INJURY.

    Additional Manufacturer Narrative · 0

    THE PREVIOUSLY REPORTED FOLLOW UP REPORT, MDR 2518422-2021-05218-1 WAS INCORRECTLY SUBMITTED WITH THE INFORMATION OF MDR 2518422-2022-05218-1.

    Additional Manufacturer Narrative · 0

    IN PREVIOUS REPORTS SECTION H10 MENTIONED INCORRECT, CORRECT H10 SHOULD BE: 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 A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO BE DIAGNOSED WITH A RESTRICTED AIRWAY, LUNGS NOT EXPANDING, LOW OXYGEN AND A COUGH. THE PATIENT WAS DIAGNOSED WHILE RECEIVING MEDICAL INTERVENTION. 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 AN UPDATED REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, A FOLLOW-UP REPORT WILL BE FILED. SECTION D9, H3 AND H6 HAS BEEN UPDATED / CORRECTED IN THIS REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO BE DIAGNOSED WITH A RESTRICTED AIRWAY, LUNGS NOT EXPANDING, LOW OXYGEN AND A COUGH. THE PATIENT WAS DIAGNOSED WHILE RECEIVING MEDICAL INTERVENTION. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524527 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O