FDA Adverse Event
Death
Summary report: N
NELLCOR N1000 MULTI-FUNCTION MONITOR
MDR report key: 262276
·
Received February 11, 2000
Report
- Report Number
- 2025525-2000-00004
- Event Type
- Death
- Date Received
- February 11, 2000
- Report Date
- February 11, 2000
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- DQA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON JANUARY 24TH 2000 MALLINCKRODT INC. REC'D INFO STATING A PT HAD EXPIRED. ACCORDING TO THE FAMILY MEMBERS, NO AUDIBLE OR VISIBLE ALARMS WERE OBSERVED ON THE N-1000 PULSE OXIMETER. NO FURTHER INFO WAS PROVIDED REGARDING THE ALLEGED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NELLCOR N1000 MULTI-FUNCTION MONITOR | PULSE OXIMETER AND CAPNOGRAPH | DQA | NELLCOR PURITAN BENNETT | N-1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |