RESPIRONICS
Report
- Report Number
- 2518422-2024-53270
- Event Type
- Malfunction
- Date Received
- August 23, 2024
- Date of Event
- August 6, 2024
- Report Date
- February 6, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNT
- UDI-DI
- 00884838089297
- PMA / PMN Number
- K102985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H10: UPDATED REPORTER FIRST AND LAST NAME, OCCUPATION. IN A GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED ON 10DEC2024, IT WAS PROVIDED BY THE AUTHORIZED SERVICE PROVIDER (ASP) THAT THE DEVICE HAD BEEN CONNECTED TO WALL OXYGEN AT THE TIME OF EVENT IT WAS CONFIRMED THAT THE DEVICE HAD BEEN IN USE AT THE TIME OF EVENT. ADDITIONALLY, THE ASP PROVIDED THE REPORTER'S NAME. ADDITIONAL GFE'S ARE BEING COMPLETED TO HAVE ONSITE SERVICE COMPLETED SO THAT A PERFORMANCE VERIFICATION TEST (PVT) CAN BE COMPLETED ON THE DEVICE. THE INVESTIGATION IS ONGOING.
IN A GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED FROM A SUPPORT ENGINEER, IT WAS PROVIDED THAT THE DEVICE HAD BEEN IN CLINICAL USE AT THE TIME OF THE REPORTED ISSUE AND STATED THAT THE ISSUE ONLY OCCURRED ONCE. AN ADDITIONAL GFE IS BEING COMPLETED TO FURTHER CLARIFY THE DEVICE USE. ADDITIONALLY, IN THE GFE RESPONSE RECEIVED THE DEVICE WAS STATED TO, AS OF THE TIME OF THE GFE RESPONSE RECEIVED, BE AT THE BIOMEDICAL ENGINEER (BME) SHOP AWAITING SERVICE. WITHIN THE GFE RESPONSE THE LOCAL AUTHORIZED SERVICE PROVIDER (ASP) PROVIDED SEVERAL PICTURES OF THE VENTILATOR SCREEN AND ALSO PROVIDED THE DEVICES DIAGNOSTIC REPORT (DRPT). REVIEWING THE PICTURE OF THE VENTILATOR SCREEN WHEN THE DEVICE WAS ALARMING, THE ALARMS PATIENT DISCONNECT (DIAGNOSTIC CODE 1200), LOW INSPIRATORY PRESSURE (DIAGNOSTIC CODE 1207), OXYGEN NOT AVAILABLE (DIAGNOSTIC CODE 1208), LOW MINUTE VENTILATION (DIAGNOSTIC CODE 120E), LOW TIDAL VOLUME DIAGNOSTIC CODE 120F), AND RUNNING ON INTERNAL BATTERY (DIAGNOSTIC CODE 1212) CAN BE SEEN. THESE ALARM CONDITIONS INDICATE A PATIENT OR VENTILATOR CONDITION THAT REQUIRES IMMEDIATE ATTENTION. AS NONE OF THESE ALARMS ARE FAILURES OF THE DEVICE WHICH WOULD LEAD TO A VENT-INOP, IT HAS BEEN DETERMINED THAT NO CLEAR DEVICE FAILURE WAS OBSERVED WITHIN THE PICTURE. ADDITIONALLY, THE CLINICAL USE OF THE DEVICE COULD NOT BE CLEARLY DEFINED WHEN REVIEWING THE PICTURE AS THE VENTILATOR CIRCUIT SETUP WAS NOT INCLUDED IN THE PICTURE FRAME. UPON REVIEWING THE DRPT, THE PREVIOUSLY MENTIONED ALARMS (DIAGNOSTIC CODES 1200, 1207, 1208, 120E, 120F, AND 1212) WERE CONFIRMED. IN ADDITION TO THESE DIAGNOSTIC CODES, SEVERAL CHANGES TO THE DEVICE'S VENTILATION SETTINGS WERE OBSERVED AMONGST THE SEVERAL PREVIOUSLY DISCUSSED DIAGNOSTIC CODES. THE DRPT WAS REVIEWED WITH A PHILIPS CLINICAL EXPERT WHO, BASED ON THE INFORMATION PRESENT IN THE DRPT, COULD NOT IDENTIFY A DEVICE FAILURE AND DID NOT OBSERVE ANY SETTINGS CHANGES THAT WERE INDICATIVE OF A CLINICAL ISSUE. THE CLINICAL EXPERT DID NOTE THAT AMONGST THE CHANGES TO THE DEVICE'S VENTILATION SETTINGS, THERE WAS NEVER A CHANGE OF THE LOW TIDAL VOLUME ALARM THRESHOLD SETTING, SO THE CLINICAL EXPERT WAS UNABLE TO DETERMINE AT WHAT TIDAL VOLUME THE LOW TIDAL VOLUME ALARM SHOULD HAVE BEEN TRIGGERING. WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED IF THE LOW TIDAL VOLUME ALARM WAS BEING TRIGGERED AS DESIGNED OR AS THE RESULT OF A DEVICE FAILURE. MULTIPLE GFE'S WERE ATTEMPTED TO OBTAIN CLARIFICATION ON THE SETUP OF THE CUSTOMER VENTILATION CIRCUIT, CLARIFICATION ON IF THE DEVICE WAS ATTACHED TO A TEST LUNG CIRCUIT OR AN ACTUAL PATIENT, IF THE DEVICE WAS ATTACHED TO WALL OXYGEN (O2) OR AN O2 TANK, CONFIRMATION OF THE CUSTOMER INSTITUTION NAME AND ADDRESS, AND A LIST OF THE VENTILATION SETTINGS THAT THE CUSTOMER HAD THE VENTILATOR SET TO AT THE TIME OF THE ALLEGED TIDAL VOLUME ALARM ISSUE. IN A GFE RESPONSE FROM THE KEY MARKET REPRESENTATIVE RECEIVED, THE CUSTOMER INSTITUTION NAME AND CUSTOMER INSTITUTION ADDRESS WERE CONFIRMED. HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER SITE REGARDING THE REST OF THE INFORMATION REQUESTED. DUE TO THIS, PHILIPS IS UNABLE TO CONFIRM THE CUSTOMERS ALLEGED TIDAL VOLUME ISSUE. ADDITIONALLY, THE FINAL DISPOSITION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.
IN A GFE RESPONSE FROM THE ASP RECEIVED ON 03FEB2025, INFORMATION RECEIVED FROM THE COMPLETED SYSTEM EVALUATION INDICATED THAT THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTING, THE TECHNICIAN WAS UNABLE TO CONFIRM THE FAILURE WHILE CONFIRMING THE DEVICE MEETS THE MANUFACTURER SPECIFICATION. INFORMATION RECEIVED FROM THE ASP CONFIRMED THAT THE DEVICE HAS BEEN RETURNED FOR USE/ IN OPERATION.
H10: E1- (B)(6) HOSPITAL. 5 LOWER KENT RIDGE RD, (B)(6). IN A GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED FROM A SUPPORT ENGINEER, IT WAS PROVIDED THAT THE DEVICE HAD BEEN IN CLINICAL USE AT THE TIME OF THE REPORTED ISSUE AND STATED THAT THE ISSUE ONLY OCCURRED ONCE. AN ADDITIONAL GFE IS BEING COMPLETED TO FURTHER CLARIFY THE DEVICE USE. ADDITIONALLY, IN THE GFE RESPONSE RECEIVED THE DEVICE WAS STATED TO, AS OF THE TIME OF THE GFE RESPONSE RECEIVED, BE AT THE BIOMEDICAL ENGINEER (BME) SHOP AWAITING SERVICE. THE INVESTIGATION IS ONGOING.
H11: E1: EVENT COUNTRY: (B)(6).
PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE WAS FAILING TIDAL VOLUME. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THIS INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1313602 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS, INC. | V60 V60PLUS VENTILATOR | 00884838089297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |