BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 13753420 · Received March 13, 2022

    Report

    Report Number
    2518422-2022-07191
    Event Type
    Malfunction
    Date Received
    March 13, 2022
    Date of Event
    February 24, 2022
    Report Date
    May 10, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030725
    PMA / PMN Number
    K113068
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REPORTED AN ALLEGATION OF AN BREATHING PROBLEM, NAUSEA, FILTER TURNED BLACK RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. SECTION B5 HAS BEEN CORRECTED AND SHOULD BE REPORTED AS: THE MANUFACTURER RECEIVED INFORMATION ALLEGING BREATHING PROBLEM, NAUSEA, FILTER TURNED BLACK RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. THERE WAS NO MENTION OF VISUAL FINDINGS TO THE EXTERNAL PART OF THE DEVICE. THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE NO ERRORS FOUND. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION. SECTION H6 UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-07191-1 WAS INCORRECTLY CREATED. PLEASE DISREGARD THE PREVIOUS MDR.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED THAT THE DEVICE CAUSED HEADACHE. THERE WAS NO REPORT OF PATIENT HARM/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
    1219296 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. FR565S 00606959030725

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown