SERVO-I BASE UNIT
Report
- Report Number
- 8010042-2025-0000634
- Event Type
- Malfunction
- Date Received
- April 23, 2025
- Date of Event
- April 15, 2025
- Report Date
- April 23, 2025
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.
ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. ALSO TECHNICAL ERROR 29, 10001 AND 24 WERE GENERATED BY THE DEVICE. TECHNICAL ERROR 3 IS A POWER ERROR WHICH INFORM ABOUT SITUATION WHERE +12 V TOO LOW, I.E. < +10.8 V, A POWER SYSTEM RESTART MIGHT BE NECESSARY TO RESET POWER RELATED ALARMS. TO RESTART, SWITCH OFF THE SYSTEM AND DISCONNECT THE MAINS POWER SUPPLY. ACCORDING TO INFORMATION RECEIVED IN THE SERVICE REPORT, THE MONITORING PRINTED CIRCUIT BOARD WAS DEFECTIVE. DEVICE LOGS WERE NOT PROVIDED. THE CAUSE OF THE CLAIMED ISSUE IN THIS CUSTOMER PRODUCT COMPLAINT HAS BEEN DETERMINED. THE REPORTED ISSUE WAS RELATED TO MONITORING PRINTED CIRCUIT BOARD.
DURING THE INSPECTION OF THE VENTILATOR, IT WAS DISCOVERED THAT TECHNICAL ERROR CODE INDICATING POWER ERROR WAS GENERATED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).
MANUFACTURER'S REF. #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515545 | SERVO-I BASE UNIT | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB | 6487800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |