FDA Adverse Event
Malfunction
Summary report: N
USED SCD RESPONSE COMPRSN SYS
MDR report key: 3192542
·
Received June 19, 2013
Report
- Report Number
- 1717344-2013-00440
- Event Type
- Malfunction
- Date Received
- June 19, 2013
- Report Date
- June 18, 2013
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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
THE CUSTOMER SENT THE SCD CONTROLLER BACK TO STOCK. THE CONTROLLER WAS RECEIVED AT COVIDIEN SERVICE CENTER. UPON TRIAGE, A SERVICE TECH FOUND THAT THE POWER CORD IS DAMAGED. THE INTERNAL COPPER WIRES ARE EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278881 | USED SCD RESPONSE COMPRSN SYS | SCD CONTROLLER | JOW | COVIDIEN | U7325 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |