BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12664372 · Received October 20, 2021

    Report

    Report Number
    2518422-2021-05432
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    January 1, 2021
    Report Date
    July 4, 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 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 CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT LEUKEMIA AND HAD A BONE MARROW TRANSPLANTS. THE REPORTED EVENT OF HAVING LEUKEMIA WAS REVIEWED BY THE PMS CLINICAL EXPERT. THIS EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME ADDITIONAL INFORMATION WAS RECEIVED AND ADDED TO THE REPORT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER ON 03/29/2023 FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED ON 06/15/2023. THE DEVICE WAS EVALUATED EXTERNALLY AND THE MANUFACTURER OBSERVED DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED AND THE MANUFACTURER OBSERVED THE EVIDENCE OF WATER INGRESS ON THE BLOWER AND BLOWER BOX . THE MANUFACTURER OBSERVED SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857 (V1). THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WAS ONE ERROR (ER 2243857 (V1)) FOUND. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE MANUFACTURER CONCLUDES THAT THEY CONFIRM THE PRESENCE OF CONTAMINATION IN THE AIRPATH AND THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE AND THE SOURCE OF CONTAMINATIONS WERE EXTERNAL TO THE DEVICE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LEUKEMIA. THE PATIENT HAD A BONE MARROW TRANSPLANT IN RESPONSE TO THE REPORTED EVENT. 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
    1564947 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization