FDA Adverse Event
Malfunction
Summary report: N
EVITA XL
MDR report key: 4834197
·
Received May 20, 2015
Report
- Report Number
- 9611500-2015-00073
- Event Type
- Malfunction
- Date Received
- May 20, 2015
- Manufacturer
- DRAGER MEDICAL GMBH
- Product Code
- MSX
- PMA / PMN Number
- K961687
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION WAS STARTED BUT IS NOT YET CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
REF IMP #2517967-2015-00028.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329853 | EVITA XL | VENTILATORS, INTENSIVE CARE | MSX | DRAGER MEDICAL GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |