FDA Adverse Event
Injury
Summary report: N
SAVINA
MDR report key: 2011599
·
Received March 1, 2011
Report
- Report Number
- 9611500-2011-00005
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- July 5, 2010
- Report Date
- February 28, 2011
- Manufacturer
- DRAEGER MEDICAL GMBH
- Product Code
- CBK
- PMA / PMN Number
- K003065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING AN EXPERTISE MEETING INVOLVING ALL PARTIES ON (B)(6) 2011, THE REPRESENTATIVE OF THE HOSPITAL CLEARLY STATED THAT THERE WAS NO MALFUNCTION OF FAILURE OF THE SAVINA. NO SIMILAR USER ERRORS REGARDING THE SAVINA HAVE BEEN REPORTED. SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SERIOUS ILL PATIENT IN COMA WAS CONNECTED TO A VENTILATOR SAVINA AND THAT VENTILATION SETTINGS WERE DONE, BUT NOT CONFIRMED TO START VENTILATION. CONSEQUENTLY THE PATIENT WAS NOT VENTILATED. REPORTEDLY CARDIAC ARREST WAS DETECTED AND THE PATIENT REANIMATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAVINA | VENTILATORS, INTENSIVE CARE | CBK | DRAEGER MEDICAL GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |