FDA Adverse Event
Other
Summary report: N
NONIN MODEL 8004CB
MDR report key: 4316314
·
Received December 5, 2014
Report
- Report Number
- 2183646-2014-00004
- Event Type
- Other
- Date Received
- December 5, 2014
- Date of Event
- November 2, 2014
- Report Date
- December 3, 2014
- Manufacturer
- NONIN MEDICAL, INC.
- Product Code
- DQA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
POTENTIAL CAUSES FOR THIS ALLEGED INCIDENT ARE LABELLED FOR IN OUR INSTRUCTIONS FOR USE. THESE INSTRUCTIONS MAY NOT HAVE BEEN FOLLOWED RESULTING IN THE ALLEGED INCIDENT.
Description of Event or Problem · 1
THE ALLEGED REPORT IS OF PATIENT INJURY STATED AS A 'BURN'. THE PHOTOS RECEIVED SHOW ONLY EEG LEADS AND A COMPETITIVE SENSOR ATTACHED TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786106 | NONIN MODEL 8004CB | OXIMETER | DQA | NONIN MEDICAL, INC. | 8004CB | 36803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |