BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PRO C-FLEX+W/HTHUMSYSONE60SRSDOM

    MDR report key: 12323967 · Received August 16, 2021

    Report

    Report Number
    2518422-2021-03230
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    April 2, 2019
    Report Date
    June 22, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005846
    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 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 A CPAP DEVICE'S SOUND ABATEMENT FOAM AND CAUSED A PATIENT TO DEVELOP LUNG CANCER. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE REPORTED EVENT OF CANCER IN THE PATIENT'S LUNGS AND ITS REPORTED SEVERITY WAS REVIEWED BY THE MANUFACTURE'S CLINICAL EXPERT. THIS EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, THE MANUFACTURE CONCLUDES NO FURTHER ACTION IS NECESSARY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT HAS SWAPPED OUT THE DEVICE AT THE DISTRIBUTOR AND AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. SECTION(S) B1, B2, HAS CHANGED RELATED TO THE COMPLAINT CHANGING FROM THE REPORTED ADVERSE EVENT TO A PRODUCT PROBLEM. SECTION H1 HAS CHANGED TO REFLECT A MALFUNCTION. SECTION H6 HEALTH EFFECT- IMPACT CODE, TYPE OF INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAS BEEN UPDATED.

    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 ON (B)(6) 2021 ; UPDATED TO ON (B)(6) 2019. G4: PREMARKET IDENTIFICATION: PREVIOUSLY REPORTED AS K113068 ; UPDATED TO K091319.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2021-03230-2 WITH INCORRECT SECTIONS B1, B2, H1, H6. CORRECTIONS TO PREVIOUS MDR ARE MADE IN THIS REPORT AS FOLLOWS. SECTION B1 WAS CORRECTED TO ADVERSE EVENT AND PRODUCT PROBLEM. (ONLY PRODUCT PROBLEM WAS CHECKED IN PREVIOUS MDR) SECTION B2 WAS CORRECTED TO OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. (PREVIOUSLY IT WAS BLANK) SECTION H1 WAS CHANGED FROM MALFUNCTION TO SERIOUS INJURY. SECTION H6- HEALTH IMPACT CODE WAS UPDATED.

    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. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. 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
    1223475 REMSTAR PRO C-FLEX+W/HTHUMSYSONE60SRSDOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS460TS 00606959005846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other