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

Model Number EFP

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Code Available (3191)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Info indicates pump shuts off without alarms and front case lettering is faded.

Manufacturer Narrative

Device returned.Complaint could not be confirmed.

• Brand Name: ENTERALITE INFINITY EFP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICE GROUP; salt lake city UT
• Manufacturer Contact: katherine kenner, sr, specialist ; 4314 zevex park ln.; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 4201116
• MDR Text Key: 5150989
• Report Number: 1722139-2014-00141
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2014

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 Number: EFP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2014
• Initial Date Manufacturer Received: 08/09/2014
• Initial Date FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1