BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 12883303 · Received November 29, 2021

    Report

    Report Number
    2518422-2021-07195
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Date of Event
    November 4, 2021
    Report Date
    April 25, 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
    OTHER
    Health Professional
    N

    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 REPORTED AN ALLEGATION OF AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGED DEVICE SEEMED PLUGGED UP AND HAVING PROBLEMS GETTING HIS OXYGEN, PARTICLES IN TUBING/CHAMBER. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER AND FOUND NO CONTAMINATION. AN INTERNAL VISUAL INSPECTION WAS COMPLETED BY THE MANUFACTURER AND FOUND PARTICLE CONTAMINATION IN BLOWER AND EVIDENCE OF WATER INGRESS TO MOOG BLOWER WAS OBSERVED DURING DEVICE EVALUATION. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER AND COULD NOT PULL ERROR LOG. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGREDATION AND UNIT SCRAPPED DUE TO DSX 400. IN INITIAL REPORTS SECTION B5 MENTIONED INCOMPLETE, CORRECT B5 SHOULD BE - THE PATIENT ALLEGED DEVICE SEEMED PLUGGED UP AND HAVING PROBLEMS GETTING HIS OXYGEN, PARTICLES IN TUBING/CHAMBER RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. SECTION H6 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. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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
    1782575 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX400H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown