FDA Adverse Event
Malfunction
Summary report: N
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
MDR report key: 2220138
·
Received August 4, 2011
Report
- Report Number
- 9611500-2011-00027
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- June 27, 2011
- Report Date
- August 4, 2011
- Manufacturer
- DRAEGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K093633
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL ONGOING. THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A F/U REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INFINITY WORKSTATION CRITICAL CARE HAS TURNED OFF ITSELF WITH INTERRUPTION OF VENTILATION WITHOUT ALARM. REPORTEDLY THE USERS TURNED THE UNIT OFF AND ON WITH THE BUTTON RESTART THE C500.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | INTENSIVE CARE VENTILATOR | CBK | DRAEGER MEDICAL GMBH | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |