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

Model Number INFINITY PUMP

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

Information received indicates that pump experiences error code 13.

Manufacturer Narrative

Investigation found that pump had no error code 13 in pump's history, but failed diode d7 test.New pcb board was replaced to solve the issue.Reference recall # z-0294-2013.

• Brand Name: ENTERALITE INFINITY ENTERAL FEEDING PUMP
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; salt lake city UT
• Manufacturer Contact: thanh quach ; 4314 zevex park ln.; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 3944477
• MDR Text Key: 4640161
• Report Number: 1722139-2014-00109
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/22/2014

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: INFINITY PUMP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0294-2013
• Patient Sequence Number: 1