BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 15904675 · Received December 2, 2022

    Report

    Report Number
    2518422-2022-100888
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    July 22, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED A VOLUNTARY MEDWATCH (MW 5113144) FROM FDA IN WHICH IT WAS ALLEGED A REPLACEMENT DREAMSTATION AUTO CPAP CAUSED AN END USER TO HAVE A HEADACHE, SORE THROAT, RUNNY NOSE, EAR PAIN, SINUS PAIN, COUGHING, AND SINUS INFECTIONS. THE END USER STATED THEY HAD TAKEN THREE ROUNDS OF ANTIBIOTICS AND STEROIDS AND STILL DID NOT FEEL BETTER. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT STATES THEY HAVE STOPPED USING THEIR REPLACEMENT DEVICE AND ARE USING AN OLDER MACHINE. THE USER STATED THEY DO NOT RECALL SEEING ANY PARTICLES IN THEIR DEVICE, BUT THEIR FILTERS WERE ALWAYS BLACK WHEN THEY WERE CHANGED ONCE OR TWICE PER MONTH. THE USER HAS NOT CONTACTED AN ATTORNEY BUT IS CONSIDERING IT WITH ALL THE QUESTIONS BEING ASKED. THE USER STATES THEY RETURNED THEIR OLD DEVICE. 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.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED A VOLUNTARY MEDWATCH (MW 5113144) FROM FDA IN WHICH IT WAS ALLEGED A REPLACEMENT DREAMSTATION AUTO CPAP CAUSED AN END USER TO HAVE A HEADACHE, SORE THROAT, RUNNY NOSE, EAR PAIN, SINUS PAIN, COUGHING, AND SINUS INFECTIONS. THE END USER STATED THEY HAD TAKEN THREE ROUNDS OF ANTIBIOTICS AND STEROIDS AND STILL DID NOT FEEL BETTER. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. IN THE PREVIOUS REPORT, SECTION H1 TYPE OF REPORTABLE EVENT, WAS INADVERTENTLY SELECTED AS "OTHER". IT HAS BEEN CORRECTED TO "SERIOUS INJURY" ON THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW 5113144) FROM FDA IN WHICH IT WAS ALLEGED A REPLACEMENT DREAMSTATION AUTO CPAP CAUSED AN END USER TO HAVE A HEADACHE, SORE THROAT, RUNNY NOSE, EAR PAIN, SINUS PAIN, COUGHING, AND SINUS INFECTIONS. THE END USER STATED THEY HAVE TAKEN THREE ROUNDS OF ANTIBIOTICS AND STEROIDS AND STILL DOES NOT FEEL BETTER. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384590 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS NORTH AMERICA LLC UDSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other