FDA Adverse Event
Malfunction
Summary report: N
OXYLOG 3000
MDR report key: 2140295
·
Received June 9, 2011
Report
- Report Number
- 9611500-2011-00019
- Event Type
- Malfunction
- Date Received
- June 9, 2011
- Date of Event
- May 10, 2011
- Report Date
- June 9, 2011
- Manufacturer
- DRAEGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K062267
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CONCERNED DEVICE WAS REQUESTED FOR INVESTIGATION. INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TRANSPORT OF A PATIENT INSIDE OF AN ELEVATOR, THE VENTILATOR STOPPED VENTILATING AND NO ALARM WAS HEARD. THE DISPLAY SHOWED A HINT TO CALL SERVICE. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXYLOG 3000 | TRANSPORT VENTILATOR | CBK | DRAEGER MEDICAL GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |