FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3111032
·
Received April 9, 2013
Report
- Report Number
- 8010042-2013-00056
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
OUR FIELD SVC ENGINEER HAS BEEN ON SITE AND STARTED INVESTIGATION. INFO ABOUT REPLACED PARTS HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED AFTER INVESTIGATION. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144750 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |