SERVO-I
Report
- Report Number
- 8010042-2018-00572
- Event Type
- Malfunction
- Date Received
- October 29, 2018
- Report Date
- November 28, 2018
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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).
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E201003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4). THE VENTILATOR WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER SINCE THE USER FACILITY PERFORMS REPAIR AND SERVICE BY THEMSELVES AND DID NOT REQUEST ANY SERVICE. NO VENTILATOR LOGS HAVE BEEN PROVIDED AND NO PARTS WERE RETURNED FOR INVESTIGATION. INFORMATION ABOUT THE CURRENT STATUS OF THE VENTILATOR HAS NOT BEEN PROVIDED. SINCE THERE IS NO INFORMATION ABOUT PERFORMED TROUBLESHOOTING OR REPAIR BY THE HOSPITAL, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ALARM. IT IS ALSO NOT POSSIBLE TO CONFIRM THE REPORTED EVENT SINCE NO DEVICE LOGS WERE RECEIVED FOR INVESTIGATION.
IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH O2 CONCENTRATION DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).
IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857686 | SERVO-I | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |