FDA Adverse Event
Death
Summary report: N
EVITA 4
MDR report key: 1692319
·
Received May 7, 2010
Report
- Report Number
- 9611500-2010-00020
- Event Type
- Death
- Date Received
- May 7, 2010
- Date of Event
- April 16, 2010
- Report Date
- May 7, 2010
- Manufacturer
- DRAGER MEDICAL AG & CO. KG
- Product Code
- CBK
- PMA / PMN Number
- K961687
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE COMPONENTS AND ADD'L INFO WERE REQUESTED FOR INVESTIGATION, BUT NOT YET REC'D. INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVITA 4 HAS ALARMED "PEEP VALVE INOP", BUT WHEN THE TECH WAS IN THE HOSP TO CHECK THE DEVICE, IT WAS REPORTED THAT THE VENTILATOR WAS CONNECTED TO A PT WHO DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVITA 4 | VENTILATOR CONTINUOUS | CBK | DRAGER MEDICAL AG & CO. KG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |