FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 1736756
·
Received June 24, 2010
Report
- Report Number
- 8010042-2010-00130
- Event Type
- Malfunction
- Date Received
- June 24, 2010
- Date of Event
- May 26, 2010
- Report Date
- May 26, 2010
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE VENTILATOR HAS A VENTILATION MODE NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST). A SINGLE USE NASO-GASTRIC CATHETER WITH ELECTRODES (EDI CATHETER) IS USED TO MEASURE THE ELECTRICAL ACTIVITY OF THE DIAPHRAGM WHICH IS USED TO TRIGGER VENTILATOR BREATHS SYNCHRONOUS WITH THE PT'S BREATHING EFFORTS. IT WAS REPORTED THAT AFTER USING THE EDI CATHETER FOR FIVE DAYS, IT WAS OBSERVED THAT THE EDI CATHETER'S FEEDING FUNCTION WAS NOT FUNCTIONING PROPERLY. IT WAS DECIDED TO REMOVE THE EDI CATHETER. ON PULLING, THE EDI CATHETER FELT STUCK AND WHEN IT WAS REMOVED, IT WAS NOTICED THAT THE END PART WAS MISSING. THE PT VOMITED THE MISSING PART WHICH HAD DEFRAGMENTED IN THREE PARTS. (B)(4). (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |