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

Model Number 382400

Device Problems No Device Output (1435); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/19/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien that a customer had an issue with an enteral feeding pump.On (b)(6) 2016 the customer states the unit has no power.Upon triage on (b)(6) 2016 the service tech found the unit has no sound.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of the unit had no audible alarm.The unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a capa has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6039685
• MDR Text Key: 57873338
• Report Number: 1282497-2016-00817
• 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,Followup
• Report Date: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1