FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 2111003
·
Received April 29, 2011
Report
- Report Number
- 8010042-2011-00067
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR DISPLAYED TECHNICAL ERROR CODES, INDICATING DISABLED VALVES AND COMMUNICATION FAILURE BETWEEN THE CONTROL AND MONITORING PRINTED CIRCUIT BOARDS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO-I | NONE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |