MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW; ENTERAL FEEDING PUMP

Model Number 382400

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with an enteral feeding pump.The customer states that the left button is bad.Upon triage on (b)(6) 2016 the service tech found the unit had no alarm.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6101972
• MDR Text Key: 59868738
• Report Number: 3008361498-2016-00172
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2016

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: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/12/2016
• Initial Date FDA Received: 11/15/2016
• 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