MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	383401
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer returned the enteral feeding pump with no specific error reported.Upon triage on 03-july-2018, service found the pump only had a partial display.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
One kangaroo joey was received with a complaint of a blank screen.This complaint has been verified.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• MDR Report Key: 7698870
• Report Number: 3008361498-2018-00386
• Device Sequence Number: 805390
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 08/08/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/19/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1