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

Model Number INFKIT2

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

The pump was returned to mmdg for evaluation.A dhr review was performed and found no non conformances.When the pump was returned to mmdg, the battery failed testing.This caused the pump to be unable to charge.This report is being filed for the delay in therapy that the patient experienced due to the complaint.

Event Description

The initial reporter stated that the pump would not turn on.They stated that this resulted in a 4 hour delay of therapy.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the reported complaint and delay in therapy.[(b)(4)].

• Brand Name: ENTERALITE INFINITY ENTERAL FEEDING PUMP
• Type of Device: ENTERAL INFUSION PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city, ut
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city, ut
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, ut ; 2641001112
• MDR Report Key: 10428499
• MDR Text Key: 204008891
• Report Number: 1722139-2020-00388
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: INFKIT2
• Device Catalogue Number: INFKIT2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2017
• 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: 13 YR