FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-595 PULSE OXIMETER
MDR report key: 2833488
·
Received October 30, 2012
Report
- Report Number
- 2936999-2012-00557
- Event Type
- Malfunction
- Date Received
- October 30, 2012
- Date of Event
- October 1, 2012
- Report Date
- October 30, 2012
- Manufacturer
- COVIDIEN
- Product Code
- DQA
- PMA / PMN Number
- K012891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
UNIT WAS EVALUATED AND THE SPEAKER WAS IDENTIFIED AS FAILING. THE SPEAKER WAS REPLACED. THIS PRODUCT IS NO LONGER MANUFACTURED.
Description of Event or Problem · 1
COVIDIEN RECEIVED A REPORT WHERE PRIOR TO PLACEMENT ON A PT, THE CLINICIAN NOTICED THERE WAS NO AUDIO TONE DURING POST (POWER-ON-SELF-TEST). THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXIMAX N-595 PULSE OXIMETER | PULSE OXIMETER | DQA | COVIDIEN | N-595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |