BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 18535911 · Received January 18, 2024

    Report

    Report Number
    2518422-2024-03288
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 10, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838009868
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6).

    Additional Manufacturer Narrative · 0

    H10: IT WAS CONFIRMED THE DEVICE DID NOT REQUIRE ANY FURTHER WORK REGARDING THE ALLEGATION OF INCORRECT VALUES BEING GIVEN DUE TO THE BSE NOT BEING ABLE TO DUPLICATE THE ALLEGATION. DURING THE SERVICE OF THE DEVICE, THE BSE DID NOT REQUIRE ANY REPLACEMENT PARTS FOR THE INCORRECT VALUES ALLEGATION. THE BSE SUCCESSFULLY COMPLETED PERFORMANCE VERIFICATION TESTING FOLLOWING THE SERVICE, WITH THE DEVICE PASSING ALL THE REQUIRED TESTS. THE BSE THEN CONFIRMED THAT THE DEVICES FACTORY SETTINGS WERE RESTORED BEFORE RETURNING THE DEVICE 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. IT REMAINS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED.

    Additional Manufacturer Narrative · 0

    H10: IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE BENCH SERVICE ENGINEER (BSE) RECEIVED ON 19JAN2024, IT WAS STATED THAT THE DEVICE USE AT THE TIME OF THE EVENT REMAINS UNKNOWN TO THEM. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE VALUES GIVEN BY THE DEVICE WERE NOT CORRECT. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE AT A PHILIPS BENCH REPAIR CENTER. AFTER TESTING THE DEVICE, THE ALLEGATION OF MEASUREMENTS BEING INCORRECT COULD NOT BE VERIFIED BECAUSE THE BSE OBSERVED NO ANOMALY WITH THE DEVICE. ALL THE MEASUREMENTS OBSERVED BY THE BSE WERE WITHIN THE ACCEPTABLE RANGE. GOOD FAITH EFFORT (GFE) ATTEMPTS ARE BEING COMPLETED TO CLARIFY THE DEVICE USE AT THE TIME OF THE REPORTED ISSUE. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759116 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838009868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown