FDA Adverse Event
Death
Summary report: N
SC9000
MDR report key: 1514532
·
Received October 20, 2009
Report
- Report Number
- 1220063-2009-00036
- Event Type
- Death
- Date Received
- October 20, 2009
- Date of Event
- September 15, 2009
- Report Date
- October 2, 2009
- Manufacturer
- DRAGER MEDICAL SYSTEMS, INC. (IT/M)
- Product Code
- DRT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A BRADYCARDIC, BUT THE SC9000 DID NOT ALARM. IT WAS ALSO REPORTED THAT THE MONITOR DID ALARM WHEN THE PT WAS IN ASYSTOLE. THERE WAS A PT DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SC9000 | PATIENT MONITOR | DRT | DRAGER MEDICAL SYSTEMS, INC. (IT/M) | UNK | 5220734865 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death | NO |