FDA Adverse Event
Malfunction
Summary report: N
CAPNOSTREAM20P WITH AI/ODI
MDR report key: 3784897
·
Received February 7, 2014
Report
- Report Number
- 8044004-2014-00001
- Event Type
- Malfunction
- Date Received
- February 7, 2014
- Date of Event
- January 2, 2014
- Report Date
- January 10, 2014
- Manufacturer
- ORIDION MEDICAL 1987 LTD.
- Product Code
- CCK
- PMA / PMN Number
- K112368
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE BIOMEDICAL ENGINEER REPORTED THAT THE DEVICE PASSED GROUNDING AND ELECTRICAL TESTING. COVIDIEN WAS NOT AUTHORIZED TO REPAIR THE DEVICE. COVIDIEN WILL CONTINUE TO MONITOR THIS FAILURE MODE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE PATIENT HAD A FEELING OF RECEIVING A SHOCK FROM THE SATURATION OF PERIPHERAL OXYGEN (SPO2) MAXA SENSOR ATTACHED TO THE CAPNOSTREAM 20. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80376 | CAPNOSTREAM20P WITH AI/ODI | CCK, DQA, MNR | CCK | ORIDION MEDICAL 1987 LTD. | CPNOSTREAM 20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |