SERVO-U
Report
- Report Number
- 8010042-2018-00620
- Event Type
- Malfunction
- Date Received
- November 21, 2018
- Report Date
- January 30, 2019
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K151814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
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 PERSON: (B)(4). OUR FSE (FIELD SERVICE ENGINEER) WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. THE FSE REPLACED THE GAS MODULE FIRST; HOWEVER THE ISSUE WAS RELATED TO THE BROKEN METAL SPRING IN THE NOZZLE UNIT. THE USER FACILITY UNINTENTIONALLY BROKE THE METAL PART PRIOR TO THE SERVICE THAT WAS DONE BY OUR FSE. THE NOZZLE UNIT WAS NOT RETURNED FOR INVESTIGATION. THE NOZZLE UNIT IS A PART OF THE AIR GAS MODULE AND CONSISTS OF A MEMBRANE, MOUTHPIECE AND A FEATHER SPRING. IF THE FEATHER SPRING IS BROKEN, GAS WILL LEAK INTO THE PATIENT CIRCUIT CAUSING FAILURES IN THE PRE-USE CHECK AND DURING VENTILATION A HIGHER PRESSURE THAN SET. ALARM FOR HIGH-PRESSURE WILL BE GENERATED IF USER SET LIMIT IS EXCEEDED.
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 |
|---|---|---|---|---|---|---|---|
| 937573 | SERVO-U | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |