BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP W/HUMID, DOM

    MDR report key: 12498136 · Received September 20, 2021

    Report

    Report Number
    2518422-2021-04096
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    July 21, 2021
    Report Date
    July 18, 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 PREVIOUSLY REPORTED AN ALLEGATION OF A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A SMALL SORE AND A LARGE SORE IN THE NOSE. THE PATIENT DID RECEIVE MEDICAL INTERVENTION THAT REQUIRED PRESCRIBED MEDICATION. THESE EVENTS WERE REVIEWED BY THE PMS CLINICAL EXPERT AND THE 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 WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THE BASE UNIT AND DUST/DIRT CONTAMINATION ON THE FLIP LID SEAL, AROUND THE HEATER PLATE, AND THROUGHTOUT THE AREAS OUTSIDE OF THE BLOWER BOX OF THE MACHINE IS CONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS NOT OBSERVED THROUGHOUT DEVICE ENCLOSURE, AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. BLOWER SEAL SHOWED FINE DARK CONTAMINATION THAT APPEARS CONSISTENT WITH KERTAIN CONTAMINATION OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THE MANUFACTURER FOUND ONE ERRORS FOUND (ER 2243857). THE MANUFACTURER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE IS DUST / DIRT CONTAMINATION AND THE PRESENCE OF CONTAMINATION IN THE AIRPATH, SOURCE OF CONTAMINATIONS WERE EXTERNAL TO THE DEVICE. 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.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A SMALL SORE AND A LARGE SORE IN THE NOSE. THE PATIENT DID RECEIVE MEDICAL INTERVENTION THAT REQUIRED PRESCRIBED MEDICATION. 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
    1391712 DREAMSTATION CPAP W/HUMID, DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC DSX200H11

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other