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

Model Number 382400

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/27/2016.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a feeding pump.The customer reported issue: will not turn on.Upon triage, it was found that the unit had sporatic power.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of sporadic power.The unit was triaged and the reported issue was confirmed.The potential root causes are the use of an unauthorized power adapter by the user and/or a possibly defective component.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 EPUMP - NEW
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer (Section G): COVIDIEN; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6205935
• MDR Text Key: 63703484
• Report Number: 1282497-2016-01112
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

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: Other
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Device Lot Number: C13027762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: 10/07/2016
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1