BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTO M SERIES

    MDR report key: 19103000 · Received April 14, 2024

    Report

    Report Number
    2518422-2024-19418
    Event Type
    Injury
    Date Received
    April 14, 2024
    Date of Event
    October 2, 2023
    Report Date
    June 18, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K041010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THE 510K NUMBER AS K010263. AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THE 510K NUMBER SHOULD HAVE BEEN K041010. THE MANUFACTURER HAS UPDATED SECTION G IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM UNO LEGAL LITIGATION IN REFERENCE TO A REMSTAR AUTO M SERIES WITH AN ALLEGATION OF KIDNEY CANCER. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THIS DEVICE IS NOT PART OF THE RECALL. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837505 REMSTAR AUTO M SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS510HS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other