FDA Adverse Event
Malfunction
Summary report: N
MICROSTREAM SMART CAPNOLINE O2 PEDIATRIC
MDR report key: 3207512
·
Received July 2, 2013
Report
- Report Number
- 8044004-2013-00002
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 7, 2013
- Report Date
- July 2, 2013
- Manufacturer
- COVIDIEN/FORMELRY TYCO, ORIDION MEDICAL 1987 LTD
- Product Code
- CCK
- PMA / PMN Number
- K011536
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DISCONNECT OF THE ORAL PIECE FROM THE SAMPLING LINE, DETECTED BY USER WHILE SAMPLING LINE WAS STILL IN PACKAGING. NO PT INVOLVEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302028 | MICROSTREAM SMART CAPNOLINE O2 PEDIATRIC | CO2 SAMPLING LINE WITH O2 TUBING | CCK | COVIDIEN/FORMELRY TYCO, ORIDION MEDICAL 1987 LTD | 007743 | Q1209005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |