FDA Adverse Event
Malfunction
Summary report: N
NPB 190
MDR report key: 266708
·
Received February 29, 2000
Report
- Report Number
- 8020893-2000-00002
- Event Type
- Malfunction
- Date Received
- February 29, 2000
- Date of Event
- January 7, 2000
- Report Date
- February 29, 2000
- Manufacturer
- NELLCOR PURITAN BENNETT, INC.
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON 02/23/2000, A NELLCOR PURITAN BENNETT FAILURE INVESTIGATION TECH VERIFIED THE CUSTOMER'S COMPLAINT THAT THE NPB 190 MONITOR DISPLAYED ZERO'S AND DID NOT ALARM. INITIAL INFO SUGGESTS NO PT HARM OR TREATMENT CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NPB 190 | PULSE OXIMETER | DQA | NELLCOR PURITAN BENNETT, INC. | NPB 190 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |