FDA Adverse Event
Death
Summary report: N
OXYLOG 2000PLUS
MDR report key: 2499778
·
Received March 9, 2012
Report
- Report Number
- 9611500-2012-00011
- Event Type
- Death
- Date Received
- March 9, 2012
- Date of Event
- February 29, 2012
- Report Date
- March 9, 2012
- Manufacturer
- DRAEGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K082600
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL ONGOING. THE AFFECTED DEVICE IS LOCATED IN THE REPAIR SHOP OF MFR SITE. THE LOG BOOK ANALYSIS AS WELL AS AN INITIAL DEVICE CHECK HAS NOT SHOWN ANY CONSPICUITIES. THE FINAL INVESTIGATION RESULTS WILL BE SENT WITHIN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE OXYLOG 2000PLUS HAS NOT BUILT UP PRESSURE. THE DEVICE REPORTEDLY GENERATED SEVERAL ALARMS. IT WAS REPORTED THAT AFTER THE REPORTED EVENT WITH THE OXYLOG 2000PLUS, THE PT DIED IN THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXYLOG 2000PLUS | TRANSPORT VENTILATOR | CBK | DRAEGER MEDICAL GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |