FDA Adverse Event
Malfunction
Summary report: N
ENTERALITE INFINITY EFP
MDR report key: 4201114
·
Received September 16, 2014
Report
- Report Number
- 1722139-2014-00143
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 14, 2014
- Report Date
- August 15, 2014
- Manufacturer
- MOOG MEDICAL DEVICE GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PUMP TESTED USING WATER. DELIVERED WITHIN SPEC. ALL TESTS PASSED. COMPLAINT NOT VERIFIED.
Description of Event or Problem · 1
INFO INDICATES PUMP ACCURACY FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572382 | ENTERALITE INFINITY EFP | ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICE GROUP | INFINITY EFP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |