FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-600 PULSE OXIMETER
MDR report key: 2062040
·
Received March 16, 2011
Report
- Report Number
- 2936999-2011-00142
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 18, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCOHE
- Product Code
- DQA
- PMA / PMN Number
- K012891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER REVEALED THAT THE FAILURE WAS ISOLATED TO THE SPEAKER BY SWAPPING WITH A KNOWN GOOD SPEAKER ASSEMBLY. THE CALLER REPORTED THAT THE SPEAKER WIRES WERE TORN BUT COULD NOT CONFIRM WHAT CONTRIBUTED TO THE TEAR IN THE WIRES. NO FURTHER CONCLUSION CAN BE DRAWN BY THE MANUFACTURING SITE SINCE THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXIMAX N-600 PULSE OXIMETER | PULSE OXIMETER | DQA | COVIDIEN, FORMERLY TYCOHE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |