FDA Adverse Event
Injury
Summary report: N
OXYLOG 2000 PLUS
MDR report key: 3231955
·
Received June 25, 2013
Report
- Report Number
- 9611500-2013-00043
- Event Type
- Injury
- Date Received
- June 25, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 24, 2013
- Manufacturer
- DRAGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K082600
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. INVESTIGATION RESULTS WILL BE REPORTED IN THE FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: THE MESSAGE "SPIROMETRY INOP" APPEARED SINCE (B)(6) 2013 ON AN OXYLOG 2000 PLUS TRANSPORT VENTILATOR. A DRAGER SVC TECH REPAIRED AND CHECKED THE DEVICE ON (B)(4) 2013. NEVERTHELESS, WHEN CONNECTING THE DEVICE TO A PT, THE DEVICE WAS AGAIN NOT WORKING AS EXPECTED. ALARMS FOR MV LOW AND PAW LOW WERE GENERATED. THE PT SUFFERED A SIGNIFICANT DESATURATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288641 | OXYLOG 2000 PLUS | NONE | CBK | DRAGER MEDICAL GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |