SERVO-I
Report
- Report Number
- 8010042-2018-00280
- Event Type
- Malfunction
- Date Received
- June 5, 2018
- Report Date
- October 16, 2018
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- BIOMEDICAL ENGINEER
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 BY OUR FSE (FIELD SERVICE ENGINEER). ACCORDING TO OUR FSE THE PRESSURE TRANSDUCER TEST IN PRE-USE CHECK FAILED INTERMITTENTLY. AFTER SOME TROUBLESHOOTING THE CONTROL PC BOARD WAS REPLACED. THE CONTROL PC BOARD IS NOT AVAILABLE FOR INVESTIGATION. AN EXCERPT OF THE DEVICE LOG WAS RECEIVED. THE LOG CONFIRMED THE REPORTED FAILURE. THE LOG SHOWS THAT THE MONITOR PRESSURE TRANSDUCER TEST FAILED DUE TO HIGH MEASURED 60 CMH2O PRESSURES. THIS INDICATES A STICKY MEMBRANE IN THE NOZZLE UNIT OF THE AIR GAS MODULE. THE LOG SHOWS NO INDICATION OF A FAILURE WITH THE CONTROL PC BOARD. THE CAUSE OF THE REPORTED PRE-USE CHECK FAILURE COULD NOT BE DETERMINED IN THIS INVESTIGATION. 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).
IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
MANUFACTURER REF. #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411223 | SERVO-I | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |