FDA Adverse Event
Malfunction
Summary report: N
SCD EXPRESS CONTROLLER
MDR report key: 3210114
·
Received June 27, 2013
Report
- Report Number
- 1717344-2013-00474
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Report Date
- May 31, 2013
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SCD PUMP. THE CUSTOMER REPORTS THERE IS A POWER ISSUE. THE UNIT WAS SENT TO A COVIDIEN SERVICE CENTER. UPON TRIAGE, A SERVICE TECH FOUND THAT THE POWER CORD IS DAMAGED EXPOSING THE COPPER WIRES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292514 | SCD EXPRESS CONTROLLER | SCD PUMP | JOW | COVIDIEN | U9525 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |