FDA Adverse Event
Death
Summary report: N
NELLCOR SYMPHONY N-3000
MDR report key: 153654
·
Received February 27, 1998
Report
- Report Number
- 2025525-1998-00008
- Event Type
- Death
- Date Received
- February 27, 1998
- Date of Event
- January 27, 1998
- Report Date
- February 27, 1998
- Manufacturer
- NELLCOR PURITAN BENNETT, INC.
- Product Code
- DQA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON 1/28/98, A NELLCOR PURITAN BENNETT EMPLOYEE RECEIVED A CALL INQUIRING INFO ON HOW TO DOWNLOAD THE TREND MEMORY DATA FROM AN N3000. FURTHER DISCUSSION ALLEGED THAT ON 1/27/98, A PT HAD EXPIRED WHILE BEING MONITORED BY A NELLCOR PURITAN BENNETT N3000. REPORTER STATED SHE NEEDED TO DOWNLOAD THE DATA FROM THE N3000 TO DETERMINE IF IT HAD ALARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NELLCOR SYMPHONY N-3000 | PULSE OXIMETER | DQA | NELLCOR PURITAN BENNETT, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death | OXINET 11, LOT#B10846. |