BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP A30

    MDR report key: 17735388 · Received September 13, 2023

    Report

    Report Number
    2518422-2023-22598
    Event Type
    Death
    Date Received
    September 13, 2023
    Date of Event
    March 21, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K113053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    IT WAS PREVIOUSLY REPORTED: THE MANUFACTURER BECAME AWARE OF ALLEGATION OF DEATH ON BIPAP A40 DEVICE. THE HOSPITAL SST NOTIFIED PHILIPS THE PATIENT HAD PASSED AWAY. THE HOSPITAL STATED THERE WAS NO ALLEGATION THE DEVICE CONTRIBUTED TO DEATH. CURRENTLY, THE DEVICE HAS NOT YET 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. CORRECTION TO BOX D.: THIS REPORT IS BEING FILED TO CORRECT THE DATA THAT WAS NOT AVAILABLE AT THE TIME OF THE INITIAL REPORT. THIS COMPLAINT WAS PREVIOUSLY FILED AS BIPAP A40 K121623. THE CORRECT PRODUCT BRAND NAME IS BIPAP A30 K113053, PRODUCT FDA CODE, SN#, MODEL#, UDI #. BOX H.: MANUFACTURER DATE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF ALLEGATION OF DEATH ON BIPAP A40 DEVICE. THE HOSPITAL SST NOTIFIED PHILIPS THE PATIENT HAD PASSED AWAY. THE HOSPITAL STATED THERE WAS NO ALLEGATION THE DEVICE CONTRIBUTED TO DEATH. CURRENTLY, THE DEVICE HAS NOT YET 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
    2059838 BIPAP A30 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNS RESPIRONICS, INC. 1111143
    534179 BIPAP A30 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNS RESPIRONICS, INC. 1111143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death