MAUDE Adverse Event Report: MOOG MED DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP

Model Number FLOCARE PUMP

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2013

Event Type  malfunction  

Event Description

Info received from (b)(6) indicates that pump experiences error code 13.

Manufacturer Narrative

Investigation by (b)(4) found that pump event log had error code 13.Pump pcb board was replaced.This mdr is being submitted because this device is similar to a device marketed in the united states.

• Brand Name: ENTERALITE INFINITY ENTERAL FEEDING PUMP
• Manufacturer (Section D): MOOG MED DEVICES GROUP; salt lake city UT
• Manufacturer Contact: thanh quach, sr analyst ; 4314 zevex park ln.; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 3881266
• MDR Text Key: 19719549
• Report Number: 1722139-2014-00047
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: LH
• PMA/PMN Number: K981816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FLOCARE PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2010
• 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