SERVO-U
Report
- Report Number
- 8010042-2019-00281
- Event Type
- Malfunction
- Date Received
- April 24, 2019
- Date of Event
- April 17, 2019
- Report Date
- August 29, 2019
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K180098
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- 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 PERON: (B)(4).
THE REPORTED DEVICE WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER (FSE), THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE CONTROL PC BOARD. THE REPLACED PC BOARD WAS RETURNED FOR INVESTIGATION, THE DEVICE LOGS COULD NOT BE RETURNED AS THEY WERE CONCLUDED TO BE CORRUPTED. OUR INVESTIGATION OF THE RETURNED CONTROL PC BOARD VERIFIES THAT THE BOARD IS FAULTY. INSTALLING NEW SOFTWARE WAS NOT POSSIBLE, OUR TEST DEVICE WAS UNABLE TO COMMUNICATE WITH THE RETURNED CONTROL PC BOARD. ELECTRICAL MEASURING DID NOT REVEAL ANY DEVIATIONS. THE CAUSE TO THE ERROR HAS NOT BEEN ESTABLISHED BY THIS INVESTIGATION. THE MOST PROBABLE CAUSE IS THAT ISSUE IS RELATED TO A COMPONENT ERROR.
IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR ALARMED FOR SEVERAL INTERNAL COMMUNICATION ERRORS AND STOPPED VENTILATING. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).
MANUFACTURER REF. #: 1916MCC1712.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340293 | SERVO-U | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |