SERVO-S
Report
- Report Number
- 8010042-2018-00657
- Event Type
- Malfunction
- Date Received
- December 7, 2018
- Report Date
- May 10, 2019
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- 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 #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERON: (B)(4). THE INVESTIGATION REGARDING THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE UNIT WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). CLEANING THE UNIT, AND REPLACING THE CONTROL PC (PRINTED CIRCUIT) BOARD SOLVED THE PROBLEM, THE REPLACED PC BOARD WAS RETURNED FOR INVESTIGATION. OUR INVESTIGATION OF THE RETURNED CONTROL PC BOARD DID NOT REVEAL ANY ERRORS. THE PC BOARD FUNCTION WAS ACCORDING SPECIFICATIONS. THE CAUSE TO THE REPORTED ERROR IS DEEMED TO BE RELATED TO THE CLEANING AND MAINTENANCE ROUTINES AND NOT DUE TO A DEVICE MALFUNCTION.
IT WAS REPORTED THAT THE VENTILATOR FAILED THE PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 980318 | SERVO-S | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |