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

Model Number INFKIT2

Device Problem Electrical Power Problem (2925)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to mmdg for evaluation.A serial number was also not provided, so no dhr could be completed.Because the device was not returned mmdg was unable to perform an investigation.This report is being filed because per our procedures all reports of this type of event are considered reportable.

Event Description

The initial reporter stated that the "charging cord melted into the charging port".Mmdg followed up with the initial reporter who stated that they had no further information about the complaint.[complaint (b)(4)].

• Brand Name: ENTERALITE INFINITY ENTERAL INFUSION PUMP
• Type of Device: INFUSION PUMP, ENTERAL
• 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 hardesty ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 8592647
• MDR Text Key: 145141096
• Report Number: 1722139-2019-00171
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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?: No
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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