BEUDAMED
    FDA Adverse Event Death Summary report: N

    QCL 2NET HUB ¿ US FGD

    MDR report key: 23306068 · Received October 15, 2025

    Report

    Report Number
    2518422-2025-110937
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    May 19, 2025
    Report Date
    April 27, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUSLY REPORTED BY THE MANUFACTURER: THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT FAMILY MEMBER REACHED OUT TO THE MANUFACTURER REGARDING WHAT TO DO WITH A QCL 2NET HUB THAT WAS LEFT BEHIND BY THEIR DECEASED HUSBAND. A CLINICAL ASSESSMENT DETERMINED: THERE IS NO ALLEGATION THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH. THE ALLEGED DEVICE PROVIDED IS A QCL 2NET HUB, WHICH WOULD BE AN ACCESSORY OF A DEVICE. THE QCL 2NET HUB ITSELF COULD NOT CAUSE OR CONTRIBUTE TO THE HARM BEING ALLEGED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ATTEMPTS WILL BE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THE CAUSE OF DEATH AND TO RETRIEVE THE DEVICE. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. NEW INFORMATION: THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A QCL 2NET HUB HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CLINICAL ASSESSMENT DETERMINED: THE PATIENT'S FAMILY WAS CONTACTED TO OBTAIN GOOD FAITH EFFORTS. WHEN ASKED QUESTIONS, THE CUSTOMER STATED SHE DID NOT KNOW THE DETAILS AND HUNG UP THE CALL. THE PATIENT DEATH REMAINS ASSESSED AS UNRELATED BASED ON THE INFORMATION AVAILABLE. ALSO, THE ALLEGED DEVICE PROVIDED IS A QCL 2NET HUB, WHICH WOULD BE AN ACCESSORY OF A DEVICE. THE QCL 2NET HUB ITSELF COULD NOT CAUSE OR CONTRIBUTE TO THE HARM BEING ALLEGED. BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED. A RISK ASSESSMENT WAS PERFORMED IN ACCORDANCE WITH THE MANUFACTURER¿S RISK MANAGEMENT PROCEDURES REGARDING THE REPORTED INCIDENT OF DEATH, WHICH WAS NOT ACCOMPANIED BY ANY ALLEGATION OF DEVICE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE CONCERNING THE CAUSE OF DEATH OR WHETHER THE DEVICE WAS IN USE AT THE TIME OF THE PATIENT¿S PASSING. MULTIPLE GOOD FAITH EFFORTS WERE ATTEMPTED YET UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION. UPON REVIEW, THE PATIENT DEATH REMAINS ASSESSED AS UNRELATED BASED ON THE INFORMATION AVAILABLE. ALSO, THE ALLEGED DEVICE PROVIDED IS A QCL 2NET HUB, WHICH IS A DIAGNOSTIC DEVICE ALONE. THE QCL 2NET HUB ITSELF COULD NOT CAUSE OR CONTRIBUTE TO THE HARM BEING ALLEGED. THE REPORT DOES NOT INDICATE ANY DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING ISSUE, OR OTHER DEFICIENCIES RELEVANT TO THE REPORTED HARM. BASED ON THE INFORMATION AVAILABLE, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S OUTCOME, AND NO NEW OR INCREASED RISK HAS BEEN IDENTIFIED. PHILIPS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT FAMILY MEMBER REACHED OUT TO THE MANUFACTURER REGARDING WHAT TO DO WITH A QCL 2NET HUB THAT WAS LEFT BEHIND BY THEIR DECEASED HUSBAND. A CLINICAL ASSESSMENT DETERMINED: THERE IS NO ALLEGATION THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH. THE ALLEGED DEVICE PROVIDED IS A QCL 2NET HUB, WHICH WOULD BE AN ACCESSORY OF A DEVICE. THE QCL 2NET HUB ITSELF COULD NOT CAUSE OR CONTRIBUTE TO THE HARM BEING ALLEGED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ATTEMPTS WILL BE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THE CAUSE OF DEATH AND TO RETRIEVE THE DEVICE. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449778 QCL 2NET HUB ¿ US FGD TELECOMMUNICATION ACCESSORY CBK RESPIRONICS, INC. 1127528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death