FDA Adverse Event
Malfunction
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING PUMP
MDR report key: 2890591
·
Received November 21, 2012
Report
- Report Number
- 1722139-2012-01190
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 26, 2012
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
CUSTOMER STATES THAT PUMP DOES NOT PUMP. CUSTOMER REFUSED TO PROVIDE ANY ADDITIONAL INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICES GROUP | SMALL VOLUME PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |