MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 383400

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The unit was sent to a service center for repair.Upon triage, a technician found issues with the gearbox and sensor.The unit has been repaired, and recertified per procedure.The unit was restored to proper operation.Information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the unit will not turn on, that it turns off after starting.

Manufacturer Narrative

An evaluation of the kangaroo joey pump was performed for the reported condition of ¿the unit turns off after starting.¿ the unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured in 2012 and was released meeting all manufacturing specifications.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: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6538307
• MDR Text Key: 74255219
• Report Number: 3006451981-2017-05207
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1