SERVO-I BASE UNIT
Report
- Report Number
- 8010042-2025-0000656
- Event Type
- Malfunction
- Date Received
- April 24, 2025
- Report Date
- April 24, 2025
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.
THE VENTILATOR WAS SET TO NON-INVASIVE VENTILATION (NIV) IN NASAL CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MODE WHICH REFERS TO VENTILATION WHEN THE PATIENT IS NOT INTUBATED OR TRACHEOTOMIZED AND IS BREATHING SPONTANEOUSLY. IN NASAL CPAP VENTILATION MODE, THE VENTILATOR SYSTEM ADAPTS TO VARIATIONS IN LEAKAGE TO MAINTAIN THE REQUIRED CPAP LEVEL. EXCESSIVE LEAKAGE WILL RESULT IN A HIGH PRIORITY ALARM. VENTILATION WILL RESUME AUTOMATICALLY IF THE LEAKAGE DECREASES BUT CAN ALSO BE STARTED MANUALLY BY THE USER. LEAKAGE IN NIV VENTILATION MODES ARE ANTICIPATED, THEREFORE THERE IS AN AUTOMATIC DETECTION OF PATIENT CONNECTION AND DISCONNECTION ¿ THE NIV DISCONNECTION FUNCTIONALITY. THIS ENSURES THAT VENTILATION STARTS IN A COMFORTABLE MANNER WHEN THE PATIENT INTERFACE IS APPLIED TO THE PATIENT'S FACE. IT ENSURES THAT VENTILATION STOPS WHEN THE INTERFACE IS REMOVED, AVOIDING HIGH AIR FLOWS AND ALARMS. IT IS POSSIBLE TO CONFIGURE THE NIV DISCONNECTION FUNCTIONALITY. THE SETTING WILL ENSURE A CONSTANT DISCONNECTION FLOW WHILE VENTILATION IS PAUSED (AT A HIGH FLOW OR A LOW FLOW SETTING). IT IS ALSO POSSIBLE TO DISABLE THE NIV DISCONNECTION FUNCTIONALITY. WHEN THERE IS A CONSISTENT HIGH LEAKAGE (>75%), THE AVAILABLE FLOW IS NOT ABLE TO UPHOLD THE CPAP LEVEL DUE TO THE LEAKAGE. THE FLOW IS THEN INTERRUPTED WITH A HIGH PRIORITY ALARM ACTIVATED 10 SECONDS AFTER THE FLOW IS INTERRUPTED. WHEN THE NIV DISCONNECTION FUNCTIONALITY IS CONFIGURED TO LOW FLOW, I.E. WHEN DISCONNECT IS DETECTED, A BIAS FLOW OF 7.5 L/MIN IS STARTED TO DETECT RE-CONNECTION. VENTILATION IS RESUMED WHEN LEAKAGE IS LOWER THAN THE SYSTEM CAN MANAGE OR WHEN RESUME VENTILATION BUTTON IS PRESSED BY THE USER. CHANGING THE NIV DISCONNECTION FUNCTIONALITY IN THE STARTUP CONFIGURATION TO DISABLED WOULD CAUSE THE SYSTEM TO CONTINUE DELIVERING GAS EVEN WHEN THE LEAKAGE IS TOO HIGH, AND THE CORRESPONDING LEAKAGE ALARM WOULD INSTEAD BE A MEDIUM PRIORITY ALARM ACTIVATED. THIS ALARM WILL BE ACTIVATED WITHOUT THE 10 SECOND DELAY APPLIED WHEN LOW FLOW DISCONNECT SETTING IS USED. NIV DISCONNECTION FUNCTIONALITY IN THIS CASE WAS SET TO LOW FLOW. A RECOMMENDATION TO THE USER WAS TO DISABLE THE NIV DISCONNECTION FUNCTIONALITY DUE TO THE EXCESSIVE LEAKAGE. THE VENTILATOR WILL THEN CONTINUE TO DELIVER ASSIST EVEN WHEN THE LEAKAGE IS EXCESSIVE. DISABLE THE NIV DISCONNECTION FUNCTIONALITY IS RECOMMENDED BUT WITH THE ADVICE TO USE EXTERNAL MONITOR TO ENSURE PATIENT SAFETY. THE RECOMMENDATION WAS FOLLOWED, AND THE NIV DISCONNECTION FUNCTIONALITY WAS CHANGED. THE CONCLUSION IS THAT THERE ARE NO INDICATIONS OF VENTILATOR MALFUNCTION DURING THE VENTILATION PERIOD. THE VENTILATOR FUNCTIONED AS IT SHOULD UNDER THE PREVAILING CIRCUMSTANCES. HOWEVER, THE ALARM GENERATION INDICATES THAT THE VENTILATION BECAME INSUFFICIENT DUE TO VENTILATOR SETTINGS CHOSEN BY THE OPERATOR IN COMBINATION WITH AN EXCESSIVE LEAKAGE IN THE PATIENT CIRCUIT.
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM WHEN UTILIZING NIV CPAP MODE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
MANUFACTURER'S REF #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727317 | SERVO-I BASE UNIT | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB | 6487800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |