BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 15977434 · Received December 14, 2022

    Report

    Report Number
    2031642-2022-03114
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 17, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HE REMOVED BEZEL (RP-BEZEL, FRONT, NON-ENGLISH, V60) WAS RETURNED TO THE PRODUCT INVESTIGATION LAB (PI). THE PIL TECHNICIAN INSTALLED THE BEZEL (RP-BEZEL, FRONT, NON-ENGLISH, V60) INTO A PI VENTILATOR TO DUPLICATE THE REPORTED ISSUE. VISUAL INSPECTION OF THE BEZEL (RP-BEZEL, FRONT, NON-ENGLISH, V60) REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE BEZEL (RP-BEZEL, FRONT, NON-ENGLISH, V60) WAS TESTED, THE FAILURE WAS CONFIRMED. PIL FOUND NAV-RING WOULD NOT ADJUST LOAD TESTER LEDS. THE NAV RING IS DEFECTIVE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT IT WAS OBSERVED THAT THE DEVICE HAS NAV-RING FAILURE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. THERE WAS NEITHER DELAY IN THERAPY NOR MEDICAL INTERVENTION REPORTED. THE MANUFACTURER'S PRODUCT SUPPORT ENGINEER (PSE) EVALUATED THE DEVICE AND CONFIRMED THAT THE NAVIGATION RING WAS UNRESPONSIVE. THE CUSTOMER REPLACED THE FRONT BEZEL TO RESOLVE THE REPORTED ISSUE . THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. ROOT CAUSE: IT WAS DETERMINED THAT LIQUID INGRESS DUE TO THE VARIABILITY OF THE ASSEMBLY PROCESS CAUSED THE REPORTED NAVIGATION RING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023855 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown