SERVO-I
Report
- Report Number
- 8010042-2018-00697
- Event Type
- Malfunction
- Date Received
- December 21, 2018
- Report Date
- January 24, 2019
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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).
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 SOFTWARE WAS RELOADED. THE DC/DC & STANDARD CONNECTORS PRINTED CIRCUIT BOARD (PCB) WAS REPLACED AND RETURNED FOR INVESTIGATION. THE DC/DC & STANDARD CONNECTORS PCB WAS INSTALLED IN A VENTILATOR FOR SIMULATED USE TESTING. NO ALARMS WERE GENERATED OR OTHER PROBLEM OCCURRED DURING THE TEST. THE DC/DC & STANDARD CONNECTORS PCB WAS WORKING AS EXPECTED. EVALUATION OF THE RECEIVED LOG FILE CONFIRMS THE BOOT UP PROBLEM. BASED ON THE DEVICE LOG EVALUATION OUR CONCLUSION IS THAT THE PROBLEM WAS LIKELY CAUSED BY AN INTERNAL COMMUNICATION ERROR AND IT WAS RESOLVED BY A RE-INSTALLATION OF THE SAME SOFTWARE VERSION.
IT WAS REPORTED THAT THE VENTILATOR DID NOT START. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
IMPORTER REF. #: CC-CPL-2018-01928. MANUFACTURER REF. #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1028525 | SERVO-I | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |