BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM

    MDR report key: 6973293 · Received October 24, 2017

    Report

    Report Number
    2031642-2017-03406
    Event Type
    Death
    Date Received
    October 24, 2017
    Date of Event
    September 27, 2017
    Report Date
    February 4, 2025
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNS
    PMA / PMN Number
    K053168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A PATIENT DEATH WHILE ON A BIPAP FOCUS VENTILATOR; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE SERIAL NUMBER OF THE DEVICE COULD NOT BE OBTAINED. THE CUSTOMER FACILITY INDICATED THAT THE VENTILATOR DID NOT CAUSE NOR CONTRIBUTE TO THE PATIENT'S DEATH. THERE WAS NO ALLEGATION BY THE CUSTOMER THAT THE DEVICE MALFUNCTIONED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    IT WAS CONFIRMED BY THE MEDICAL ENGINEER ONSITE THAT THE DEVICE DID NOT MALFUNCTION. THEREFORE, THE DEVICE DID NOT CAUSE NOR CONTRIBUTE TO THE PATIENT'S DEATH. NO EVALUATION WAS PERFORMED BY A FIELD SERVICE ENGINEER ON THIS DEVICE AS UPON ONSITE VISIT, THE VENTILATOR WAS IN USE ON ANOTHER PATIENT AND NOT AVAILABLE; ANY SETTINGS OR INFORMATION WOULD HAVE BEEN INAPPLICABLE. NO FURTHER INFORMATION HAS BEEN PROVIDED WITH REGARD TO THE PATIENT AND DEVICE.

    Additional Manufacturer Narrative · 0

    H10: PHILIPS' FIELD SERVICE ENGINEER DID CORRECTIVE MAINTENANCE ON THE DEVICE AND WERE UNABLE TO CORRECT THE REPORTED PROBLEM. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE.FURTHER INFORMATION WAS REQUESTED ABOUT THE PATIENT AND OUTCOME AND WAS REFUSED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    B4: 05JUN2019. G4:05JUN2019. THE CUSTOMER FACILITY INDICATED THAT THE VENTILATOR DID NOT CAUSE NOR CONTRIBUTE TO THE PATIENT'S DEATH. THERE WAS NO ALLEGATION BY THE CUSTOMER THAT THE DEVICE MALFUNCTIONED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ***DO NOT PROCESS ***

    Description of Event or Problem · 0

    ***DO NOT PROCESS***

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER HARD CODED IN THE FILE IS NOT ACCURATE. WE DO NOT CURRENTLY KNOW THE DEVICE SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE FIELD SERVICE ENGINEER REPORTED THERE WERE NO KNOWN ISSUES WITH THE VENTILATOR AT THE TIME OF THE PATIENT DEATH. FURTHER INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT DEATH WHILE ON A BIPAP FOCUS VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752563 BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS CALIFORNIA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death