SERVO-U
Report
- Report Number
- 8010042-2018-00334
- Event Type
- Malfunction
- Date Received
- July 6, 2018
- Date of Event
- June 29, 2018
- Report Date
- October 19, 2018
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K151814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).
THE VENTILATOR WAS INVESTIGATED AT SITE BY OUR FIELD SERVICE ENGINEER. THE AIR GAS MODULE WAS REPLACED BUT NOT RETURNED FOR INVESTIGATION. THE EVALUATION OF THE RECEIVED DEVICE LOGS CONFIRMS THE REPORTED ALARMS FOR HIGH O2 CONCENTRATION, I.E. THE O2 CONCENTRATION BECOMES HIGHER THAN THE UPPER ALARM LIMIT WHICH IS SET VALUE +5 VOL%. TOGETHER WITH THE ALARMS FOR HIGH O2 CONCENTRATION, THERE ARE ALSO ALARMS FOR VOLUME DELIVERY RESTRICTED AND AIRWAY PRESSURE HIGH. THE SET VENTILATION MODE WAS SIMV PRVC (PRESSURE REGULATED VOLUME CONTROL). IN A PRVC MODE THE VENTILATOR DELIVERS A PRE-SET TIDAL VOLUME AND THE PRESSURE IS AUTOMATICALLY REGULATED TO DELIVER THE PRE-SET VOLUME, BUT IT IS LIMITED TO THE SET UPPER PRESSURE LIMIT. THE ALARM FOR VOLUME DELIVERY RESTRICTED IS GENERATED WHEN THE SET VOLUME IS NOT ATTAINED, DUE TO IMPOSED RESTRICTION OF THE SET UPPER PRESSURE LIMIT. AIRWAY PRESSURE HIGH ALARM INDICATES THAT VENTILATION WAS ONGOING BUT WITH HIGHER AIRWAY PRESSURE THAN INTENDED. IT IS GENERATED WHEN THE USER SET UPPER PRESSURE LIMIT IS REACHED WHEREBY THE INSPIRATION PHASE IS TERMINATED AND GOES OVER TO EXPIRATION. THIS LEADS TO THAT THE PATIENT IS NOT RECEIVING THE SET VOLUME AND THIS MAY EITHER BE RELATED TO USER SETTINGS NOT BEING OPTIMAL FOR THE ACTUAL PATIENT, OR AN INCREASED EXPIRATORY RESISTANCE IN THE PATIENT¿S BREATHING SYSTEM. THE TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. THERE IS NO RELATIONSHIP BETWEEN THE HIGH O2 CONCENTRATION ALARMS AND THE INDICATION OF EXPIRATORY RESISTANCE IN THE PATIENT¿S BREATHING SYSTEM. SINCE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE HIGH O2 CONCENTRATION ALARMS HAS NOT BEEN DETERMINED. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE AND AIR GAS MODULE WERE REPLACED AND RETURNED FOR INVESTIGATION. THE AIR AND O2 GAS MODULE REGULATES THE INSPIRATORY AIR AND OXYGEN GAS FLOW TO THE PATIENT. THE REPORTED ALARM FOR HIGH O2-CONCENTRATION WAS REPRODUCED DURING SIMULATED USE TEST OF THE RETURNED O2 GAS MODULE AND AIR GAS MODULE IN A VENTILATOR, BUT NO INDICATION OF HIGH PRESSURE. THE O2 GAS MODULE WAS FOUND TO BE OSCILLATING IN THE VENTILATOR AND IN THE PRODUCTION TEST SYSTEM FOR GAS MODULES. THE OSCILLATIONS WERE CAUSED BY A FAULTY NOZZLE UNIT. THE AIR-GAS MODULE WAS FOUND FAULTLESS. THE NOZZLE UNIT HAS A PREDETERMINED LIFETIME AND IS REPLACED AT PREVENTIVE MAINTENANCE (PM) THAT MUST BE PERFORMED EVERY 5000 HOURS OF OPERATION OR AT LEAST ONCE A YEAR. IN THIS CASE THE NOZZLE UNIT FAILED PREMATURELY. IF THIS FAULT HAPPENS DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION.
IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, ALARMS FOR HIGH O2 CONCENTRATION AND HIGH PRESSURE WERE GENERATED. THERE WAS NO PATIENT HARM. (B)(4).
MANUFACTURER REF. #:(B)(4).
MANUFACTURER REF. #:(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510253 | SERVO-U | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |