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

Model Number 382401

Device Problems Power Conditioning Problem (1474); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The unit was sent to a service center for repair.Upon triage, a technician found was unable to verify the customer's complaint.The unit's, firmware was updated, tested and recertified per procedure.The unit was restored to proper operation and returned to the customer.

Event Description

It was reported to covidien on (b)(6) 2017 that an issue occurred with an enteral feeding pump.The customer states that the unit's power won't stay on.

• Brand Name: KANGAROO EPUMP - RFB
• 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: 6401525
• MDR Text Key: 70081378
• Report Number: 3008361498-2017-00162
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2017
• 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