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

Model Number 23401-001

Device Problem Electrical Power Problem (2925)

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

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to mmdg for evaluation.During the investigation mmdg was able to confirm the complaint.The charger housing had heated up and been burned by a faulty resistor.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 "heat was dissipated" from the power cord and that it had resulted in a burn hole forming in the housing of the charger.Mmdg made multiple follow up attempts to obtain additional information from the initial reporter regarding the complaint, however, no further information was made available.(b)(4).

• Brand Name: ENTERALITE INFINITY AC ADAPTER
• 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: 8034611
• MDR Text Key: 126370561
• Report Number: 1722139-2018-00259
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/04/2018

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
• Device Operator: Other
• Device Model Number: 23401-001
• Device Catalogue Number: 23401-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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