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

Model Number	INFP01
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump was not returned to mmd for evaluation.A dhr review was completed and no non-conformance's were found.Because the device was not returned to mmd an investigation could not be completed.This report is being filed for the reported delay in therapy that the patient experienced as a result of the complaint.
Event or Problem Description
The initial reporter stated that the pump was alarming no flow in almost immediately after they pressed the run button to start the feeding.They stated that this resulted in an eight hour delay of therapy while the patient was at school.Mmd did follow up with the initial reporter who stated that there were no adverse effects as a result of the complaint.They stated that the patient was able to eat by mouth after they when home and that a replacement pump was delivered.They did not provide any additional information.[complaint: (b)(4)].

• Brand Name: ENTERALITE INFINITY 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; 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: 24368563
• Report Number: 1722139-2026-00056
• Device Sequence Number: 9679888
• Product Code: LZH
• UDI-Device Identifier: 10814844000181
• UDI-Public: 10814844000181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: INFP01
• Device Catalogue Number: INFP01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• 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 Age: 10 YR
• Patient Sex: Unknown