BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 15280188 · Received August 23, 2022

    Report

    Report Number
    2031642-2022-02216
    Event Type
    Death
    Date Received
    August 23, 2022
    Date of Event
    August 12, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNS
    PMA / PMN Number
    K053168
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON INFORMATION RECEIVED FROM THE RESPIRATORY THERAPIST DIRECTOR, IT WAS INDICATED THAT THERE WAS NO DEVICE MALFUNCTION AND IDENTIFIED IT AS A PATIENT ISSUE. THE RESPIRATORY THERAPIST DIRECTOR INDICATED THAT THE DEVICE WAS ALARMING AS DESIGNED IN THE EVENT OF THE ABSENCE OF SPONTANEOUS BREATH. BASED ON THE INFORMATION RECEIVED THE DEVICE WAS OPERATING PER THE DESIGN SPECIFICATIONS.

    Description of Event or Problem · 0

    THE INSTITUTIONAL BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PATIENT PASSED AWAY. A RESPIRATORY TECHNICIAN FOUND THE MASK HALFWAY OFF THE FACE OF THE USER. THE DEVICE DID ALARM AND WAS WORKING WELL BEFORE THE INCIDENT. A PATIENT OF UNKNOWN AGE, GENDER AND MEDICAL HISTORY WAS PLACED ON THE BIPAP FOCUS FOR AN UNKNOWN INDICATION. ON (B)(6) 2022, WHILE THE DEVICE WAS IN CLINICAL USE, THE PATIENT PASSED AWAY. A RESPIRATORY TECHNICIAN FOUND THE MASK TO BE HALFWAY OFF THE PATIENT¿S FACE. THE CUSTOMER INDICATED THAT THE DEVICE DID ALARM AND WAS WORKING WELL BEFORE THE INCIDENT. NO OTHER CLINICAL DETAILS WERE PROVIDED. THE CUSTOMER REQUESTED FOR AN ON-SITE SERVICE. AS END-OF-LIFE CLASSIFICATION OF MANUFACTURING, DISTRIBUTION, AND USE OF BIPAP FOCUS HAS BEEN DESIGNATED AS OF (B)(6) 2019, A PHILIPS REMOTE SERVICE ENGINEER (RSE) PROVIDED A PRODUCT DISCONTINUANCE LETTER TO THE CUSTOMER AND WAS ADVISED TO FIND A THIRD PARTY TO SERVICE THE VENTILATOR. THE RSE ALSO REACHED OUT TO SALES TO FIND OUT IF AN AREA MANAGER (AM) HAS KNOWLEDGE OF THE BIPAP FOCUS TO PROVIDE ASSISTANCE WITH ANY QUESTIONS. THE CUSTOMER IS SEEKING 3RD PARTY EVALUATION OF THE DEVICE. FURTHER INFORMATION HAVE BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324686 RESPIRONICS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS CALIFORNIA, LLC BIPAP FOCUS SYSTEM, INT'L, RENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death