BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12638552 · Received October 15, 2021

    Report

    Report Number
    2518422-2021-05372
    Event Type
    Death
    Date Received
    October 15, 2021
    Date of Event
    December 28, 2020
    Report Date
    June 17, 2022
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    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 A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND ALLEGEDLY CAUSED A PATIENT TO DEVELOP LUNG CANCER. THE PATIENT EXPIRED. DESPITE MULTIPLE ATTEMPTS, THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. CORRECTION TO SECTION D4. SERIAL NUMBER (B)(6) MODEL #CAX500T12 AND UDI (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. SECTION H1 WAS CORRECTED TO REFLECT "DEATH" AS REPORTED IN SECTION B2 OF THE ORIGINAL REPORT. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    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. THE PATIENT EXPIRED. 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
    1538887 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS RESPIRONICS, INC. CAX500T12

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death