BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 19347210 · Received May 17, 2024

    Report

    Report Number
    2518422-2024-29287
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    October 6, 2023
    Report Date
    June 11, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Removal / Correction Number
    Z-1972-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: SECTION B: ADVERSE EVENT/PRODUCT PROBLEM UPDATED FROM "PRODUCT PROBLEM" TO "BOTH".

    Additional Manufacturer Narrative · 0

    PHILIPS CANNOT RELATE THE NUMBER OF HEALTH ISSUES MENTIONED IN THE NRC ARTICLE TO INDIVIDUAL COMPLAINTS RECEIVED DIRECTLY, VIA LAWYERS OR VIA DISTRIBUTORS OR IGJ. WITHOUT FURTHER DETAILS, PHILIPS IS NOT ABLE TO CONDUCT ANY FURTHER INDIVIDUAL INVESTIGATION OF THESE ALLEGATIONS, AND IS NOT ABLE TO CONFIRM WHETHER THE PHILIPS DEVICES MAY HAVE CONTRIBUTED TO THE HEALTH CONSEQUENCES MENTIONED ABOVE. PHILIPS REFERS TO THE PREVIOUSLY COMMUNICATED OUTCOMES OF ITS EXTENSIVE TESTING PROGRAM ASSOCIATED WITH THE PRODUCT FAMILIES REFERRED TO IN THE ALLEGATIONS. H3 OTHER TEXT : DEVICE NOT RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 0

    IN AN ARTICLE IN NRC NEWSPAPER DATED SEPTEMBER 30, 2023, SAP LAWYERS (¿SAP¿) WAS QUOTED, STATING THAT OF ITS CLIENTS, CA 70 PEOPLE HAVE CANCER, CA 450 HAVE RESPIRATORY ISSUES LIKE ASTHMA, RESPIRATORY SYSTEM IRRITATION AND SHORTNESS OF BREATH, CA 300 HAVE HEADACHES AND DIZZINESS AND CA 40 INFLAMMATION REACTIONS. PHILIPS HAS CONTACTED SAP, ASKING FOR A COMPREHENSIVE SUBSTANTIATION PER CLIENT/PATIENT OF THE HEALTH ISSUES MENTIONED IN THE NRC NEWSPAPER, INCLUDING A LINK TO THE SERIAL NUMBERS OF THE POTENTIALLY AFFECTED DEVICES. PHILIPS HAS CONTACTED SAP VIA E-MAILS AND PHONE CONVERSATIONS IN ORDER TO RETRIEVE ADDITIONAL INFORMATION. SAP EXPLAINED THAT ITS QUOTE WAS BASED ON INFORMATION PROVIDED BY ITS CLIENTS UPON THEIR INTAKE PROCESS. DUE TO AVG/GDPR REASONS AND THE FACT THAT SAP DOES NOT HAVE THE INFORMATION AVAILABLE IN A WAY THAT IT CAN EASILY EXTRACT THE RELATED INFORMATION PER PATIENT/DEVICE, SAP DID NOT SHARE THE REQUESTED COMPREHENSIVE SUBSTANTIATION. SAP DID INFORM PHILIPS THAT THEY HAVE REQUESTED EACH CLIENT, UPON THEIR INTAKE, TO REPORT ANY COMPLAINT THEY MAY HAVE TO IGJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668394 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other