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

Model Number 382400

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the feeding pump's main board component is burnt.There is no reported patient involvement.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿according to the reporter, the feeding pump's main board component is burnt.There is no reported patient involvement.¿ the device history record (dhr) for serial number (b)(4) indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.All dhrs are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Product cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The unit was returned and disassembled for further evaluation.Visual inspection of the main pcba found a component had thermal damage consistent with a short.No contamination, corrosion, or signs of ingress were found.The cause of the short is unknown.The potential root cause is the use of an unauthorized power adapter by the user, component failure or general wear and tear.The reported customer complaint was confirmed.A root cause could not be determined.The probable root cause was determined to be the use of an unauthorized power adapter by the user, component failure or general wear and tear.This complaint will be utilized for tracking and trending purposes.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: 8001744
• MDR Text Key: 124972916
• Report Number: 3006451981-2018-00619
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1