FDA Adverse Event
Malfunction
Summary report: N
PRIMUS
MDR report key: 2073123
·
Received March 23, 2011
Report
- Report Number
- 9611500-2011-00008
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 11, 2011
- Report Date
- March 23, 2011
- Manufacturer
- DRAGER MEDICAL GMBH
- Product Code
- BSZ
- PMA / PMN Number
- K042607
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. THE INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT SUDDENLY THE DEVICE STOPPED WORKING WITHOUT WARNING AND WITHOUT MESSAGE ON THE SCREEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMUS | ANESTHESIA MACHINE | BSZ | DRAGER MEDICAL GMBH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |