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

Model Number	INFORNG
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated that the pump had damage to the hinges, door latch, and keypad.When the pump was returned to mmd for evaluation, the no flow out alarm did not alarm as expected.It failed to alarm.The initial reporter stated that the complaint had occurred during testing and had not had any adverse effect on a patient.The alarm failure was discovered at moog.(b)(4).
Additional Manufacturer Narrative
The pump was returned to mmd for evaluation.A dhr review was completed and no non-conformances were found.During the investigation, mmd found that the pump pcb board had failed, which caused the no flow out alarm to fail.The pump was serviced to correct the issue.

• Brand Name: ENTERALITE INFINITY ORANGE ENTERAL FEEDING PUMP
• Common Device Name: ENTERAL INFUSION PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 21575434
• Report Number: 1722139-2025-00117
• Device Sequence Number: 20889283
• Product Code: LZH
• UDI-Device Identifier: 10814844000334
• UDI-Public: 10814844000334
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K031199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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
• Operator of Device: Other
• Device Model Number: INFORNG
• Device Catalogue Number: INFORNG
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown