FDA Adverse Event Malfunction Summary report: N

ENTERALITE INFINITY ENTERAL FEEDING PUMP

MDR report key: 2842189 · Received October 22, 2012

Report

Report Number
1722139-2012-01072
Event Type
Malfunction
Date Received
October 22, 2012
Date of Event
September 5, 2012
Report Date
September 25, 2012
Manufacturer
MOOG MEDICAL DEVICES GROUP
Product Code
LZH
PMA / PMN Number
K031199
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

PUMP WAS NOT RETURNED.

Description of Event or Problem · 1

INFO REC'D INDICATES THAT PUMP IS NOT ALARMING WHEN THE BAG IS EMPTY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

Patients

Seq Age Sex Outcome Treatment
1 4 YR ELECARE JR VANILLA