RESPIRONICS
Report
- Report Number
- 2518422-2023-28352
- Event Type
- Malfunction
- Date Received
- October 31, 2023
- Date of Event
- October 16, 2023
- Report Date
- March 9, 2026
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNT
- UDI-DI
- 00884838020054
- PMA / PMN Number
- K102985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE PRODUCT INVESTIGATION LAB (PIL) HAS CONFIRMED A HARDWARE FAILURE IN THE ARTESYN POWER SUPPLY (P/N 1041938) AFTER TESTING VERIFIED A 0VDC OUTPUT ACROSS ALL CIRCUITS. WHILE THE COMPONENT IS CONFIRMED FAULTY, IT IS CURRENTLY OUT OF WARRANTY AND HAS BEEN OBSOLETED IN FAVOR OF THE MEGMEET SWITCHING POWER SUPPLY. BECAUSE THIS IS A VENDOR-SUPPLIED ITEM AND PHILIPS DOES NOT MAINTAIN DESIGN CONTROL, NO FURTHER ROOT CAUSE ANALYSIS OR TESTING WILL BE PERFORMED. ADDITIONALLY, THE CURRENT VENDOR (ADVANCED ENERGY) NO LONGER SUPPORTS THIS MODEL, LEADING POST MARKET AND SUPPLIER QUALITY TO CONCLUDE THAT NO FURTHER ACTION IS REQUIRED. FAULTY POWER SUPPLY CONFIRMED.
H10: THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND COULD NOT CONFIRM THE REPORTED PROBLEM. THE POWER SUPPLY WAS INSTALLED, AND IT WORKED FINE. HOWEVER, THE DEVICE DID NOT PASS THE REQUIRED PERFORMANCE VERIFICATION TESTS ON THE AIR FLOW SENSOR. IT NEEDS A NEW FLOW SENSOR ASSEMBLY OR GDS. THIS NEW ISSUE WILL BE HANDLED ON ANOTHER CASE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME REGARDING THE POWER SUPPLY. IF ADDITIONAL INFORMATION IS RECEIVED IN REGARD TO THE POWER SUPPLY, THE COMPLAINT FILE WILL BE REOPENED.
H10: AFTER FURTHER TROUBLESHOOTING AND REPAIR BY THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE), IT WAS NOTED THAT AFTER REPLACING THE GAS DELIVERY SYSTEM (GDS), IT WAS OBSERVED THAT THE AC POWER WAS NOT CONNECTED. THE V60 WAS RUNNING ON INTERNAL BATTERY. THE POSSIBLE SOLUTION IS TO INSTALL A NEW AC INLET, A NEW POWER SUPPLY, OR A NEW CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE INVESTIGATION IS ONGOING.
H10: THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THE REPORTED PROBLEM. THE FSE OBSERVED THAT THE AC POWER WAS NOT CONNECTED, THE V60 WAS RUNNING INTERNAL BATTERY. THE FSE REPLACED THE POWER SUPPLY, THE CENTRAL PROCESSING UNIT (CPU) BOARD, AND THE AC INLET 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. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. BASED ON INFORMATION PROVIDED AND/OR SERVICE PERFORMED IT HAS BEEN CONFIRMED UNIT DID NOT MEET PRODUCT SPECIFICATIONS. IT WAS DETERMINED THAT THE POWER SUPPLY, CPU, AC INLET WAS THE CAUSE OF THE REPORTED ISSUE. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED. ALTHOUGH REQUESTED, THE DEFECTIVE PARTS WERE NOT RECEIVED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE PART IS RECEIVED AND EVALUATED.
THE REMOVED POWER SUPPLY WAS RETURNED TO THE PRODUCT INVESTIGATION LAB. THE PIL TECHNICIAN INSTALLED POWER SUPPLY INTO PI VENTILATOR TO ATTEMPT DUPLICATION OF THE REPORTED ISSUE. VISUAL INSPECTION REVEALED NO DAMAGE OR CONTAMINATION. ALL OPERATING VOLTAGES WERE PRESENT ON THE POWER BOARD WITH OPEN CIRCUIT VOLTAGES VERIFIED WAND WITHIN SPECIFICATION. IT WAS THEN TESTED UNDER A 10.45 LOAD FOR 20 MINUTES, DURING WHICH THE 24 VDC OUTPUT REQUIRED FOR V60 OPERATION REMAINED WITHIN SPECIFICATION. THE PIL TECHNICIAN ALSO VERIFIED THAT THE PIL STB, WITH THE SUSPECT POWER SUPPLY TEMPORARILY INSTALLED, OPERATED WITHOUT ISSUE OR ERROR CODES FOR APPROXIMATELY 1 HOUR. WITH THE PIL STB BATTERY INSTALLED, THE BATTERY ACCEPTED A CHARGE DURING UNIT OPERATION, AND THE AC POWER CHARGING LED SEGMENTS WERE ILLUMINATED AS EXPECTED. THE PIL TECHNICIAN WAS UNABLE TO REPLICATE THE REPORTED ISSUE AND CLASSIFIED THIS AS NO PROBLEM FOUND.
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT DURING SET UP WHEN UNIT IS PLUGGED INTO AC POWER THE UNIT, IT DOES NOT POWER ON AND NO FRONT BEZEL LEDS WERE ILLUMINATED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE CUSTOMER TRIED DIFFERENT A POWER CORD AND AC OUTLETS, BUT PROBLEM PERSISTED, SO REPAIR WAS REQUESTED. THE RSE DISPATCHED A FIELD SERVICE ENGINEER FOR ONSITE SERVICE AND REPAIR. INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24396 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS, INC. | V60 | 00884838020054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |