BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER

    MDR report key: 12519596 · Received September 23, 2021

    Report

    Report Number
    2518422-2021-04185
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    September 17, 2021
    Report Date
    January 17, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030220
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. A CORRECTION HAS BEEN MADE TO SECTION B5 AND 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 RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE CPAP DEVICE'S SOUND ABATEMENT FOAM.. THE PATIENT HAS ALLEGED TO EXPERIENCING A SEVERE COUGH COUGH WITH ALOT OF SPUTUM AND HAS ALLEGED TO SEEING BLACK PARTICLES IN THE MASK. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER EVALUATION. THE DEVICED POWERED ON AND PROVIDED AIRFLOW. UPON EXTERNAL EXAMINATION VERY LITTLE WEAR AND TEAR WAS OBSERVED. INTERNAL EVALUATION REVEALED LIGHT DUST CONTAMINATION IN THE INTERIOR OF THE DEVICE ENCLOSURE, AND FINE DUST CONTAMINATION OF THE BLOWER. HE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER AND FOUND 0 ERRORS LOGGED. THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE MANUFACTURER CONCLUDES THE CONTAMINATION FOUND WAS CONSISTENT WITH DUST. THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION FOUND WITHIN THE DEVICE.

    Description of Event or Problem · 1

    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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419832 REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DE462S 00606959030220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown