FDA Adverse Event
Malfunction
Summary report: N
NORTH AMERICAN DRAGER
MDR report key: 274228
·
Received April 12, 2000
Report
- Report Number
- 2025525-2000-00007
- Event Type
- Malfunction
- Date Received
- April 12, 2000
- Date of Event
- March 14, 2000
- Report Date
- April 11, 2000
- Manufacturer
- NELLCOR PURITAN BENNETT
- Product Code
- DQA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 3/14/2000 NPB WAS INFORMED THAT A NORTH AMERICAN DRAGER ALLEGEDLY PROVIDED HIGH READINGS. ACCORDING TO THE CALLER NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NORTH AMERICAN DRAGER | PULSE OXYMETER | DQA | NELLCOR PURITAN BENNETT | NAD | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |