FDA Adverse Event
Malfunction
Summary report: N
ENTERALITE INFINITY ENTERAL FEEDING PUMP
MDR report key: 3023283
·
Received February 28, 2013
Report
- Report Number
- 1722139-2013-00136
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 1, 2012
- Report Date
- February 19, 2013
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Removal / Correction Number
- Z-0294-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FOUND THAT THE DIODE D7 WAS DETERMINED TO BE LEAKY AND WAS OUT OF THE SPECIFICATION. NEW PCB BOARD WAS REPLACED TO SOLVE THE ISSUE. REFERENCE RECALL # Z-0294-2013.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THAT PUMP ALARMS ERROR CODE 13.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88963 | ENTERALITE INFINITY ENTERAL FEEDING PUMP | LZH | MOOG MEDICAL DEVICES GROUP | INFINITY PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |