BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 24483596 · Received March 2, 2026

    Report

    Report Number
    2518422-2026-105606
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 9, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONTACTED PHILIPS, AND REPORTED THAT THE FLOW SENSOR ASSEMBLY WAS REPLACED; HOWEVER, THE DEVICE WAS NOT RETURNED TO SERVICE DUE TO A SEPARATE ISSUE. ASSISTANCE WAS PROVIDED TO THE CUSTOMER, AND THE REPAIR WOULD BE PERFORMED BY THE CUSTOMER. INVESTIGATION ONGOING / RESOLUTION PENDING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONTACTED PHILIPS FOR A THIRD TIME AND THE CUSTOMER MADE THE SAME ALLEGATION THAT THE DEVICE WAS DISPLAYING A CO2 REBREATHING ERROR MESSAGE. TROUBLESHOOTING WAS PERFORMED, AND THE REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE DEVICE WAS SHOWING -10.1 AIR SLPM (STANDARD LITERS PER MINUTE), WHEN THE DEVICE WAS SET TO ZERO. THE CUSTOMER REQUESTED THE PART NUMBER FOR REPLACEMENT GAS DELIVERY SYSTEM (GDS) AND FLOW SENSOR ASSEMBLY. THE CUSTOMER WAS PROVIDED WITH BOTH PART NUMBERS, AND WAS EXPECTED TO PERFORM THE REPAIR IN HOUSE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PERFORMED A FOLLOW UP WITH PHILIPS REMOTE SERVICE ENGINEER (RSE). IT WAS REPORTED THAT WHEN THE PRESSURE WAS SET TO ZERO, THE AVERAGE AIR SLPM (STANDARD LITER PER MINUTE) WAS READING A -10 (EXPECTED RANGE: -1.0 TO 1.0). THE RESULT WAS CONSIDERED OUF OF RANGE. THE RSE ADVISED THE CUSTOMER TO REPLACE THE FLOW SENSOR ASSEMBLY. THE PART NUMBER FOR A REPLACEMENT WAS PROVIDED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    INSUFFICIENT INFORMATION WAS AVAILABLE TO DETERMINE THE RESOLUTION OF THE EVENT. A FOLLOW UP WAS PERFORMED WITH THE CUSTOMER; HOWEVER, THE CUSTOMER DID NOT CONFIRM IF THE DEVICE WAS RETURNED TO SERVICE AFTER THE FLOW SENSOR ASSEMBLY WAS REPLACED. NO FURTHER DETAILS WERE PROVIDED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE COMPLAINT INVESTIGATION IS CLOSED, WITH DATA LOGGED INTO POST MARKET SURVEILLANCE FOR CONTINUED PRODUCT QUALITY MONITORING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR DISPLAYED A "LOW LEAK CO2 REBREATHING RISK" ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER'S V60 VENTILATOR DISPLAYED A "LOW LEAK CO2 REBREATHING RISK" ERROR CODE. DURING TROUBLESHOOTING, THE RSE INFORMED THE CUSTOMER, THAT THE ALARM CAN OCCUR IF THERE IS NOT ENOUGH LEAK AT THE PATIENT; IF THE PATIENT CIRCUIT HAD ENOUGH LEAK, THE RSE NOTED THAT THERE IS A FLOW SENSOR ISSUE. THE CUSTOMER WAS ADVISED TO PERFORM A FULL PERFORMANCE VERIFICATION TEST (PVT) AND ADDRESS THE ISSUE(S) FOUND. THE CUSTOMER WOULD CONTACT THEIR THIRD-PARTY SERVICE PROVIDER. INVESTIGATION ONGOING / RESOLUTION PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234197 RESPIRONICS VENTILATOR, CONTINUOUS USE, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60

    Patients

    Seq Age Sex Outcome Treatment
    1