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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY EFP; ENTERAL FEEDING PUMP

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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY EFP; ENTERAL FEEDING PUMP Back to Search Results
Model Number EFP
Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Patient Problem No Code Available (3191)
Event Date 05/16/2014
Event Type  malfunction  
Event Description
Information indicates product was overrunning.
 
Manufacturer Narrative
Pump tested several times and each time pump alarmed appropriately.Complaint could not be confirmed.
 
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Brand Name
ENTERALITE INFINITY EFP
Type of Device
ENTERAL FEEDING PUMP
Manufacturer (Section D)
MOOG MEDICAL DEVICES GROUP
salt lake city UT
Manufacturer Contact
katherine kenner, senior ras
4314 zevex park ln.
salt lake city, UT 84123
MDR Report Key4203892
MDR Text Key5152070
Report Number1722139-2014-00124
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEFP
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/26/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/18/2014
Initial Date FDA Received07/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23 YR
Patient Weight51
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