MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 383400

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 6/1/2017.

Event Description

It was reported to covidien that a customer had an issue with an enteral feeding pump.Upon triage of the unit, on (b)(6) 2017, service found a burnt component.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of a physically burnt fuse.The unit was triaged and the customer¿s reported condition was confirmed.The potential root causes are the use of an unauthorized power adapter by the user and/or a possibly defective component.A review of the device history record shows that this unit was manufactured in 2012 and was released meeting all manufacturing specifications.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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 789 puxing rd; building 10; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN; 789 puxing rd; building 10; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6605934
• MDR Text Key: 76499853
• Report Number: 3006451981-2017-05309
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

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: Health Professional
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 11/08/2017
• 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: Initial
• Patient Sequence Number: 1