FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION IV PUMP
MDR report key: 2943664
·
Received January 9, 2013
Report
- Report Number
- 1722139-2013-00033
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 14, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND THAT PUMP SHOWED IMPACT BENT PLATEN CAUSING PLATEN WILL NOT CLOSE TO PERFORM TEST. PLATEN WAS REPLACED TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THAT PATIENT'S DOOR IS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13136 | CURLIN INFUSION IV PUMP | FRN | MOOG MEDICAL DEVICES GROUP | 6000 PAINSMART IOD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |