BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTOA-FLEX W/ HUM, SYSONE 60SRS, AUS

    MDR report key: 12310916 · Received August 11, 2021

    Report

    Report Number
    2518422-2021-02875
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    August 5, 2021
    Report Date
    December 23, 2024
    Manufacturer
    RESPORINOC INC
    Product Code
    BZD
    UDI-DI
    00606959005495
    PMA / PMN Number
    K091319
    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 PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058. CORRECTED DATA: E1 INITIAL REPORTER (CONTACT/PHONE NUMBER): PREVIOUSLY REPORTED AS (B)(6). G4 PMA/510(K) NUMBER: PREVIOUSLY REPORTED AS K113068 ; UPDATED TO K091319.

    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 A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND THE PATIENT DEVELOPED A MASS IN HIS LUNGS. THE DETAILS OF THE PATIENT'S REQUIRED MEDICAL INTERVENTION ARE UNKNOWN. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING AN UPDATED REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, A FOLLOW-UP REPORT WILL BE FILED. SECTION H6 UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND THE PATIENT DEVELOPED A MASS IN HIS LUNGS. PATIENT SUFFERED FROM PNEUMONIA, HAS COPD & ASTHMA. THE DETAILS OF THE MEDICAL INTERVENTION THAT THE PATIENT REQUIRED ARE CURRENTLY UNKNOWN. IN PREVIOUS MDR HEALTH CLINICAL CODES ARE MISSING IN THIS REPOT CORRECTED AND UPDATED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND THE PATIENT DEVELOPED A MASS IN HIS LUNGS. THE DETAILS OF THE MEDICAL INTERVENTION THAT THE PATIENT REQUIRED ARE CURRENTLY UNKNOWN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202682 REMSTAR AUTOA-FLEX W/ HUM, SYSONE 60SRS, AUS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPORINOC INC AU561HS 00606959005495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other