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

Model Number EFP

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Date 05/24/2014

Event Type  malfunction  

Event Description

Information indicates that the pump was delivering under the programmed accuracy.

Manufacturer Narrative

Pump was tested for accuracy several times, each time it functioned within specification.Complaint not 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: 4207589
• MDR Text Key: 22003230
• Report Number: 1722139-2014-00128
• 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: 06/24/2014

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?: Yes
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2011
• 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
• Patient Age: 8 MO
• Patient Weight: 5