BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 19134842 · Received April 18, 2024

    Report

    Report Number
    2518422-2024-17937
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    January 25, 2024
    Report Date
    July 25, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 10/22/2024, AND SECTION H10 SHOULD BE REPORTED AS: THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW5152443) IN WHICH THE PATIENT ALLEGES SHORTNESS OF BREATHING AND EMPHYSEMA. THE PATIENT STATING THAT SHE USED THE RECALLED PHILIPS DREAMSTATION 1 CPAP FROM 2019 UNTIL SHE RECEIVED THE REPLACEMENT DREAMSTATION 2 MACHINE IN 2021. THE PATIENT REPORTED THAT SHE NOTICED HAVING "SHORTNESS OF BREATH AT TIMES AND HOARSENESS IN HER VOICE" AND HAS CHEST X-RAY IN 2024. THE PATIENT STATED HER THOUGHTS THAT IT "SHOWED HER LUNGS ARE HYPERINFLATED SUGGESTING EMPHYSEMA"; THAT SHE HAVE APPOINTMENTS WITH A PULMONOLOGIST AND AN ENT SPECIALIST THIS MONTH. MEDICAL INTERVENTION WAS NOT SPECIFIED. THERE IS NO CUSTOMER INFORMATION HENCE WE CANNOT REACH OUT TO THE CUSTOMER 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. IN BOX H: EVALUATION METHOD CODE, EVALUATION RESULTS CODE, COMPONENT CODE GRID AND CONCLUSION CODE GRID HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5152443) IN WHICH THE PATIENT ALLEGES SHORTNESS OF BREATHING AND EMPHYSEMA. THE PATIENT STATING THAT SHE USED THE RECALLED PHILIPS DREAMSTATION 1 CPAP FROM 2019 UNTIL SHE RECEIVED THE REPLACEMENT DREAMSTATION 2 MACHINE IN 2021. THE PATIENT REPORTED THAT SHE NOTICED HAVING ¿SHORTNESS OF BREATH AT TIMES AND HOARSENESS IN HER VOICE¿ AND HAS CHEST X-RAY IN 2024. THE PATIENT STATED HER THOUGHTS THAT IT ¿SHOWED HER LUNGS ARE HYPERINFLATED SUGGESTING EMPHYSEMA¿; THAT SHE HAVE APPOINTMENTS WITH A PULMONOLOGIST AND AN ENT SPECIALIST THIS MONTH. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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
    539772 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown