FDA Adverse Event
Malfunction
Summary report: N
4000CMS
MDR report key: 3221369
·
Received July 1, 2013
Report
- Report Number
- 1722139-2013-02265
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- January 1, 2010
- Report Date
- September 27, 2010
- Manufacturer
- MOOG DEVICE GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IMPACT: PLATEN BENT CAUSING FAILED 40 PSI TEST. REPLACED PLATEN ASSEMBLY.
Description of Event or Problem · 1
INFO REC'D STATES THAT PUMP'S DOOR PLATEN IS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297342 | 4000CMS | FRN | MOOG DEVICE GROUP | 4000CMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |