FDA Adverse Event
Malfunction
Summary report: N
MPS2 CONSOLE
MDR report key: 773323
·
Received August 14, 2006
Report
- Report Number
- 1649914-2006-00073
- Event Type
- Malfunction
- Date Received
- August 14, 2006
- Report Date
- August 14, 2006
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- DTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THAT THE CONSOLE HAS DISPLAYED "MECHANISM ERROR" TOWARDS THE END OF THE CASE, SEVERAL CASES IN A ROW. THE TWO ERROR CODES INVOLVED ARE 196 AND 178. THE CONSOLE WILL BE RETURNED TO QUEST FOR INVESTIGATION. PRODUCT CODE 5201260.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MPS2 CONSOLE | CARDIOPLEGIA DELIVERY SYSTEM--HARDWARE | DTR | QUEST MEDICAL, INC. | 5201260 | 2059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |