FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 4672443
·
Received April 7, 2015
Report
- Report Number
- 8010042-2015-00128
- Event Type
- Malfunction
- Date Received
- April 7, 2015
- Report Date
- March 11, 2015
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT, THE EDI CATHETER WAS READING A HIGH EDI PEAK PRESSURE AND WOULD NOT LOWER. THE EDI CATHETER WAS REPLACED WITH ANOTHER ONE WITH THE SAME LOT NUMBER. THE NEW CATHETER WORKED FINE. THERE WAS NO PT HARM. THE EDI CATHETER IS USED DURING NAVA (NEURALLY ADJUSTED VENTILATOR ASSIST) TO DETECT THE ELECTRICAL ACTIVITY IN THE DIAPHRAGM. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228266 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |