FDA Adverse Event Malfunction Summary report: N

RESPIRONICS

MDR report key: 23406433 · Received October 28, 2025

Report

Report Number
2518422-2025-050097
Event Type
Malfunction
Date Received
October 28, 2025
Date of Event
October 10, 2025
Report Date
October 28, 2025
Manufacturer
RESPIRONICS, INC.
Product Code
MNT
PMA / PMN Number
K102985
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT ERROR CODE 1109 MACHINE PRESSURE SENSOR AUTOZERO FAILED OCCURRED. 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. NO MEDICAL INTERVENTION PROVIDED TO THE PATIENT, NOR A DELAY WAS NOTED. THE AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE DEVICE AND CONFIRMED THE REPORTED PROBLEM. THIS ISSUE APPEARS TO BE INTERMITTENT, HAVING OCCURRED ONLY ONCE SO FAR. IT HAS BEEN DETERMINED TO REPLACE THE SOLENOID VALVE TO RESOLVE ISSUE. PER GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED 24OCT2025, IT WAS CONFIRMED THAT THE UNIT HAS BEEN REPAIRED AND RETURNED TO SERVICE. THE CUSTOMER REPORTED A PRESSURE MALFUNCTION ERROR, WHICH COULD NOT BE DUPLICATED DURING TESTING WITH CUSTOMER SETTINGS. AN ERROR CODE 1109 INDICATED A FAILED PRESSURE SENSOR, LEADING TO THE REPLACEMENT OF SOLENOIDS 2 AND 4 IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS, FOLLOWED BY PREVENTIVE MAINTENANCE TESTS. THE SOLENOID VALVE WAS INDEED REPLACED TO RESOLVE THE ISSUE. AFTER REPAIRS, THE DEVICE SUCCESSFULLY PASSED PERFORMANCE SPECIFICATION TESTING, AS CONFIRMED BY PERFORMANCE VERIFICATION TESTS, AND IS NOW BACK IN SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
233901 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown