FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3111049
·
Received April 19, 2013
Report
- Report Number
- 8010042-2013-00062
- Event Type
- Malfunction
- Date Received
- April 19, 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
OUR FIELD SERVICE ENGINEER (FSE) WHO WAS DISPATCHED TO SITE COULDN'T DUPLICATE THE TECHNICAL ERROR CODES. THE FSE DOWNLOADED THE VENTILATOR'S LOGS AND REPLACED THE CONTROL PRINTED CIRCUIT BOARD AS A PRECAUTION. EVALUATION OF THE LOGS AND INVESTIGATION OF THE PRINTED CIRCUIT BOARD IS ANTICIPATED. 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 |
|---|---|---|---|---|---|---|---|
| 170196 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |