FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3121702
·
Received May 8, 2013
Report
- Report Number
- 8010042-2013-00065
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO PARTS HAVE BEEN REPLACED. THE INVESTIGATION WILL CONSIST OF A DEVICE LOG EVAL. ADD'L DETAILS OF THE PT'S CONDITION AND THE REPORTED EVENT HAVE BEEN REQUESTED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202422 | SERVO-I | CBK | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |