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

Model Number EFP

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Code Available (3191)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

Information indicates the product displayed error code 13.

Manufacturer Narrative

Device not returned to manufacturer.

• 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, sr. specialist ; 4314 zevex park ln.; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 4207571
• MDR Text Key: 5042689
• Report Number: 1722139-2014-00129
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EFP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1