MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; FEEDING PUMP

Model Number 383401

Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/19/2016.An investigation is currently underway.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 reports: during biomed testing: unit turns off on its own sporadically during use.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states ¿unit turns off on its own sporadically during use.¿ the unit was triaged and the reported issue could not be confirmed at this time.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 JOEY,PUMP W/CLMP,REFB
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): SHANGHAI; building # 10, 789 puxing road; shanghai ; CH
• MDR Report Key: 5959741
• MDR Text Key: 55038529
• Report Number: 3006451981-2016-00409
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

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
• Device Operator: Other
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Device Lot Number: F15063460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: 09/14/2016
• Supplement Dates FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1