FDA Adverse Event
Death
Summary report: N
DELTA XL
MDR report key: 2247929
·
Received September 8, 2011
Report
- Report Number
- 1220063-2011-00046
- Event Type
- Death
- Date Received
- September 8, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 17, 2011
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
- Product Code
- MHX
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING OPEN HEART SURGERY, THIS DELTA X MONITOR WAS DISPLAYING CARDIAC OUTPUT AND SVR VALUES OF ABOUT 6 AND 600 RESPECTIVELY. THE USER REPORTED THAT MEDICATION WAS DELIVERED TO THE PT BASED ON THE VALUES DISPLAYED. THE PT WAS TRANSFERRED TO THE ICU FROM THE OPERATING ROOM AND WAS CONNECTED TO A DATEX OHMEDA MONITOR THAT DISPLAYED CARDIAC OUTPUT AND SVR VALUES OF 1.9 AND 2500 RESPECTIVELY. THE USER REPORTED THAT THE PT EXPIRED A FEW DAYS AFTER THE SURGERY. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA XL | PATIENT MONITOR | MHX | DRAEGER MEDICAL SYSTEMS, INC. (IT/M) | MS13476 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death | NO |