FDA Adverse Event
Malfunction
Summary report: N
SCP-10 SENSOR INTERFACE CABLE
MDR report key: 1063567
·
Received June 18, 2008
Report
- Report Number
- 2936999-2008-00305
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- April 28, 2008
- Report Date
- June 13, 2008
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED BY THE USER FACILITY. THERE HAS BEEN NO SIMILAR COMPLAINTS REPORTED FOR THIS PRODUCT.
Description of Event or Problem · 1
THE NPB295 OXIMETER PROVIDED 100% READINGS AND IT WAS ISOLATED TO THE SCP-10 CABLE. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCP-10 SENSOR INTERFACE CABLE | SCP-10 INTERFACE CABLE | DQA | COVIDIEN, FORMERLY TYCO HEALTHCARE | SCP-10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |