BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS RESPIRONICS REMSTAR

    MDR report key: 12507402 · Received September 21, 2021

    Report

    Report Number
    2518422-2021-04275
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    June 15, 2021
    Report Date
    August 28, 2023
    Manufacturer
    RESPIRONICS,INC.
    Product Code
    BZD
    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 PREVIOUSLY RECEIVED INFORMATION ALLEGING ALLERGIES WORSENED,GENERAL INFLAMMATIO,AND CAUSED A PATIENT TO DEVELOP BREAST CANCER RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM.THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. THERE IS NO CUSTOMER INFORMATION AND WE CANNOT REACH OUT TO THE CUSTOMER, HENCE, ATTEMPT TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION CAN NOT BE MADE AT THIS TIME. 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 (HEALTH EFFECT - CLINICAL CODE) HAS BEEN CORRECTED AND (TYPE OF INVESTIGATION,INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW5103012) ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP BREAST CANCER. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. 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
    1406932 PHILLIPS RESPIRONICS REMSTAR VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other