FDA Adverse Event
Malfunction
Summary report: N
SCD 700 COMPRESSION SYSTEM - US
MDR report key: 3060690
·
Received March 26, 2013
Report
- Report Number
- 3006451981-2013-00078
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 21, 2013
- Manufacturer
- COVIDIEN
- Product Code
- JOW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 03/25/2013. 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SCD PUMP. THE CUSTOMER STATES AT THE TIME OF INSPECTION, THE POWER CABLE SEEMED WORN OUT. THE OUTER COATING WAS RUPTURED AND INNER COPPER WIRE WAS EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124624 | SCD 700 COMPRESSION SYSTEM - US | SCD PUMP | JOW | COVIDIEN | 29525 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |