FDA Adverse Event
Malfunction
Summary report: N
OXIMAX ADULT OXYGEN SENSOR
MDR report key: 3250112
·
Received July 23, 2013
Report
- Report Number
- 2936999-2013-00549
- Event Type
- Malfunction
- Date Received
- July 23, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 27, 2013
- Manufacturer
- COVIDIEN, FORMERLY TYCO
- Product Code
- NLF
- PMA / PMN Number
- K052186
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN REQUESTED INFORMATION ON INCIDENT SUCH AS: PLACEMENT OF THE SENSOR, HOW LONG SENSOR WAS IN USED, HOW OFTEN THE SITE WAS CHECKED/ CHANGED BUT USER FACILITY WAS NOT ABLE TO PROVIDE FURTHER DETAILS.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN SALES REPRESENTATIVE THAT MAXA SENSOR WAS PROVIDING LOW READINGS. IT WAS REPORTED THAT THE READINGS WERE IN THE 80% RANGE; CONSISTENTLY SHOWING SPO2 10% LOWER. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344128 | OXIMAX ADULT OXYGEN SENSOR | OXIMAX MAXA OXYGEN SENSOR | NLF | COVIDIEN, FORMERLY TYCO | MAXA | 131260066X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PHILIPS M3001A MODULES| MP90| MP30 |