FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-560 PULSE OXIMETER
MDR report key: 3880248
·
Received April 8, 2014
Report
- Report Number
- 2936999-2014-00329
- Event Type
- Malfunction
- Date Received
- April 8, 2014
- Date of Event
- March 1, 2014
- Report Date
- March 18, 2014
- Manufacturer
- MEDIANA
- Product Code
- DPZ
- PMA / PMN Number
- K012891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ISSUE WAS ISOLATED TO THE DISPLAY PCB. THE DISPLAY PCB WAS REPLACED. (B)(4). THE SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN THAT THE UNIT'S DISPLAY IS NOT LIGHTING UP ALL THE WAY. COVIDIEN INVESTIGATION VERIFIED THE UNIT DISPLAY WAS MISSING SEGMENTS. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211824 | OXIMAX N-560 PULSE OXIMETER | PULSE OXIMETER | DPZ | MEDIANA | N-560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |