FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION IV PUMP
MDR report key: 2890616
·
Received November 21, 2012
Report
- Report Number
- 1722139-2012-01183
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 24, 2012
- Report Date
- November 5, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND THAT PUMP SHOWED IMPACT BRENT/DAMAGED PLATEN. PLATEN WAS REPLACED TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THAT PUMP'S PLATEN DOOR IS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN INFUSION IV PUMP | FRN | MOOG MEDICAL DEVICES GROUP | 6000 PAINSMART IOD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |