FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3599161
·
Received November 26, 2013
Report
- Report Number
- 8010042-2013-00249
- Event Type
- Malfunction
- Date Received
- November 26, 2013
- Date of Event
- October 25, 2013
- Report Date
- October 28, 2013
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFO SURROUNDING THE EVENT HAS BEEN SOUGHT AND THE EDI CATHETER HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED AFTER INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT VOMITED BESIDE THE EDI CATHETER BUT A RETENTION INSPECTION DONE PRIOR TO THE VOMITING HAD NOT PRODUCED ANY LIQUID. THE EDI CATHETER HAD BEEN INSERTED LONGER THAN THE RECOMMENDED 5 DAYS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617062 | SERVO-I | CBK | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |