BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 13525239 · Received February 14, 2022

    Report

    Report Number
    2518422-2022-04068
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    September 16, 2021
    Report Date
    July 6, 2023
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY 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 RUNNING NOSE, EXHAUSTION, AND ORGAN PROBLEMS. NO OTHER PERIPHERALS OR ACCESSORIES WERE RETURNED WITH THE DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER EVALUATION. THE MANUFACTURER OBSERVED EVIDENCE OF DUST CONTAMINATION ON THE BLOWER AND IN THE BLOWER. EVIDENCE OF WATER INGRESS WAS OBSERVED ON THE BLOWER. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857 V1. USING THE FIT TOOL (ER 2245460 V1), PIL OBSERVED FOAM ADHERING TO THE TOOL CONFIRMING THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. PIL CAN CONFIRM THE PRESENCE OF DUST IN THE DEVICE AND AIRPATH. PIL CAN ALSO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM, HOWEVER NO VISIBLE AMOUNTS OF FOAM WERE OBSERVED TO BE MISSING. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER AND FOUND 0 ERRORS LOGGED. THE MANUFACTURER CONCLUDES THE DUST CONTAMINATION ON THE BLOWER AND IN THE BLOWER. EVIDENCE OF WATER INGRESS WAS OBSERVED ON THE BLOWER. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED IN ER 2243857 V1. USING THE FIT TOOL (ER 2245460 V1), PIL OBSERVED FOAM ADHERING TO THE TOOL CONFIRMING THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. CORRECTED SECTION D4 UDI NO SECTION H6 WERE 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 HAS ALSO EXPERIENCED UNBEARABLE SNEEZING AND RUNNING NOSE. 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
    1262957 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown