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

Model Number 482400S

Device Problem Loss of Power (1475)

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

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the pump lights up and immediately off.No further information is available at this time.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states ¿the pump lights up and immediately off." the unit was triaged and the customer¿s reported condition was confirmed.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
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7537387
• MDR Text Key: 109030269
• Report Number: 3006451981-2018-00386
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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: No Information
• Device Model Number: 482400S
• Device Catalogue Number: 482400S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 04/23/2018
• Supplement Dates FDA Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1