BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO W/HT HUM,SYS ONE,60 SRS,CAN

    MDR report key: 12268815 · Received August 3, 2021

    Report

    Report Number
    2518422-2021-02731
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    January 1, 2015
    Report Date
    September 17, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959014169
    PMA / PMN Number
    K091319
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: B3: DATE OF EVENT: PREVIOUSLY REPORTED AS (B)(6) 2021; UPDATED TO (B)(6) 2015. E1: ADDRESS (COUNTRY): PREVIOUSLY REPORTED AS USA; UPDATED TO CANADA. 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 VISUALIZATION OF PARTICLES RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.  SECTION H6 UPDATED IN THIS REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LUNG CANCER AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PATIENT REQUIRED SURGICAL INTERVENTION IN RESPONSE TO THE LUNG CANCER DIAGNOSIS. 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
    1163526 REMSTAR AUTO W/HT HUM,SYS ONE,60 SRS,CAN VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CA561TS 00606959014169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other