FDA Adverse Event
Malfunction
Summary report: N
SCS 700 COMPRESSION SYSTEM-US
MDR report key: 3952232
·
Received May 13, 2014
Report
- Report Number
- 1717344-2014-00417
- Event Type
- Malfunction
- Date Received
- May 13, 2014
- Date of Event
- May 7, 2014
- Report Date
- May 7, 2014
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A NON-SPECIFIC ISSUE. THE UNIT WAS RETURNED TO A LOCAL COVIDIEN SERVICE CENTER AND A SERVICE TECHNICIAN FOUND THAT THE END OF THE POWER PLUG SHOWS SIGNS OF ARCING AND BLACK SOOT WHICH CAN BE SEEN FROM THE END OF THE PLUG. THE EXTERNAL AC INPUT PIN SHOWS SIGNS WHERE ARCING OCCURRED, WHICH WERE CAUSED BY AN EXTERNAL OBJECT HITTING THE PIN WHILE PLUGGED IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285600 | SCS 700 COMPRESSION SYSTEM-US | SCD CONTROLLER | JOW | COVIDIEN | 29525 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |