BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 19344286 · Received May 17, 2024

    Report

    Report Number
    2518422-2024-29173
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 17, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BSE AGAIN CONFIRMED THAT THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST, WHICH THE DEVICE PASSED. THE BSE SET THE DEVICE TO THE CUSTOMERS LOCAL DATE/TIME AND SET THE DEVICE TO FACTORY SETTINGS. THE DEVICE WILL BE RETURNED TO THE CUSTOMER READY FOR USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE 4 AT THE REPAIR CENTER. THE BSE WAS UNABLE TO DUPLICATE THE PATIENT DISCONNECT ERROR UNLESS THE PROXIMAL TUBING WAS ACTUALLY DISCONNECTED. THE BSE BELIEVED THAT THERE MAY BE AN ISSUE WITH THE PATIENT CIRCUIT AT THE CUSTOMER SITE AND RECOMMENDED THAT THE CUSTOMER REPLACE THEIR PATIENT CIRCUIT. THE BSE ADVISED THEY WOULD PERFORM A FULL PERFORMANCE VERIFICATION TEST AT THE BENCH REPAIR CENTER. THE INVESTIGATION REMAINS ONGOING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE WAS PRODUCING PATIENT DISCONNECT ALARMS EVERY COUPLE MINUTES. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) OF THE DEVICE ISSUE AND CONFIRMED THE DEVICE¿S INTERNAL TUBING AND SETUP WAS OK. THE CUSTOMER REQUESTED BENCH SERVICE OF THE DEVICE AND WAS PROVIDED WITH THE BENCH SERVICE CENTER FORM TO SEND IN THE DEVICE EXPERIENCING THE ISSUE. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490578 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown