FDA Adverse Event
Death
Summary report: N
NELLCOR N-200
MDR report key: 320700
·
Received March 15, 2001
Report
- Report Number
- 2025525-2001-00001
- Event Type
- Death
- Date Received
- March 15, 2001
- Date of Event
- February 5, 2001
- Report Date
- March 14, 2001
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- DQA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON FEBRUARY, 2001, NELLCOR PURITAN BENNETT RECEIVED INFO THAT ALLEGED A PT HAD EXPIRED WHILE BEING MONITORED BY AN N-200 PULSE OXIMETER. ACCORDING TO THE FAMILY MEMBER, "FAMILY MEMBER DID NOT HEAR AN ALARM SOUNDING".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11657 | NELLCOR N-200 | PULSE OXIMETER | DQA | NELLCOR PURITAN BENNETT | N-200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 MO | Death | CPAP |