FDA Adverse Event
Death
Summary report: N
OXIMAX MAXA SENSOR
MDR report key: 1070250
·
Received June 27, 2008
Report
- Report Number
- 2936999-2008-00314
- Event Type
- Death
- Date Received
- June 27, 2008
- Date of Event
- April 24, 2008
- Report Date
- June 2, 2008
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTH
- Product Code
- DQA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PHILIPS' ENGINEER PERFORMED INVESTIGATION OF THE SENSOR/OXIMETER SETUP AND COULD NOT DUPLICATE THE HIGH READING. THE ENGINEER STATED THAT THERE IS "NOTHING WRONG WITH THE MONITOR AND SENSOR". COMPANY HAS REQUESTED THE MAX-A SENSOR BE RETURNED FOR FAILURE INVESTIGATION.
Description of Event or Problem · 1
COMPANY RECEIVED MEDWATCH REPORT INDICATING THE MAX-A ADHESIVE SENSOR WAS PROVIDING 100% O2 SATURATION WHILE THE PT HAD ALREADY EXPIRED. THE SENSOR WAS IN USE WITH ANOTHER COMPANY'S PULSE OXIMETRY SETUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXIMAX MAXA SENSOR | OXYGEN SENSOR | DQA | COVIDIEN, FORMERLY TYCO HEALTH | MAXA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death | MODEL M3001A| CATALOG M8002A INTELLIVUE CONTROLLER| PHILIPS INTELLIVUE MP30 |