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

Catalog Number INFKIT2

Device Problems Failure to Charge (1085); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 07/13/2013

Event Type  malfunction  

Event Description

Infinity charger for feeding pump was malfunctioning.It was not charging the feeding pump.Charger discarded.The pump, charger, operator manual, and clamp are all part of one kit.This facility has had multiple problems with this device and has been in ongoing contact with the manufacturer.It is unknown why these problems are occurring.Patients experience a delay in nutritional therapy with these events.

• Brand Name: ENTERAL LITE INFINITY
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP SRL; seneca & jamison road; east aurora NY 14052
• MDR Report Key: 3678995
• MDR Text Key: 20857390
• Report Number: 3678995
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: INFKIT2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2014
• Event Location: Home
• Date Report to Manufacturer: 03/14/2014
• Patient Sequence Number: 1
• Patient Age: 9 YR