FDA Adverse Event
Death
Summary report: N
DELTA
MDR report key: 1693089
·
Received May 17, 2010
Report
- Report Number
- 1220063-2010-00009
- Event Type
- Death
- Date Received
- May 17, 2010
- Date of Event
- January 24, 2010
- Report Date
- January 26, 2010
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
- Product Code
- MHX
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- 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 INCIDENT OCCURRED ON (B) (6) 2010, BUT DRAEGER WAS JUST RECENTLY NOTIFIED ABOUT THIS REPORTED INCIDENT. IT WAS REPORTED THAT DURING A PATIENT MONITORING IN CT, THE (B) (4)-MEASUREMENT STOPPED FUNCTIONING. INSTEAD OF (B) (4) VALUE ONLY *** WAS SHOWN. IT WAS REPORTED THAT THE PATIENT DIED. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA | PATIENT MONITOR | MHX | DRAEGER MEDICAL SYSTEMS, INC. (IT/M) | MS13466E539D | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death | NO |