FDA Adverse Event
Other
Summary report: N
ENTERALITE INFINITIY ENTERAL FEEDING PUMP
MDR report key: 1842700
·
Received September 17, 2010
Report
- Report Number
- 1722139-2010-00084
- Event Type
- Other
- Date Received
- September 17, 2010
- Date of Event
- August 31, 2010
- Report Date
- September 17, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: ACTUAL DEVICE WAS EVALUATED. RESULTS: THE EVALUATION INCLUDED PERFORMANCE TESTING (ACCURACY, VERIFICATION OF AIR/NO FOOD ALARM, ETC.). MULTIPLE FORMULAS AND SETTINGS WERE USED TO RECREATE THE FAILURE EXPERIENCED BY THE CUSTOMER. THE PUMP PERFORMED ACCORDING TO SPECIFICATIONS DURING EACH RUN (ALARMED AND SHUT OFF AFTER FOOD WAS GONE). CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. THE PUMP PERFORMED ACCORDING TO SPECIFICATION.
Description of Event or Problem · 1
INFINITY PUMP DID NOT ALARM OR SHUT DOWN AFTER FOOD WAS GONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERALITE INFINITIY ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICES GROUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |