MAUDE Adverse Event Report: COVIDIEN KANGAROO 924 U.S.; ENTERAL FEEDING PUMP

Model Number 392455

Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/01/2016.An investigation is currently underway.Upon completion, a full report shall be provided.

Event Description

It was reported to covidien on 05/10/2016 that the customer experienced an issue with an enteral feeding unit.Customer reports that the unit will not power or will power on for a few seconds and power off.No patient involvement.

Manufacturer Narrative

An investigation of kangaroo k924pump was performed for the reported condition of; the unit will not power or will power on for a few seconds and power off.The unit was triaged and the complaint was confirmed.The cause of the reported condition was due to the corrosion on the unit¿s pcb board; liquid infiltration caused the corrosion.The unit was manufactured in 2011.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: KANGAROO 924 U.S.
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5708588
• MDR Text Key: 48109871
• Report Number: 1282497-2016-00236
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/10/2016

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: 392455
• Device Catalogue Number: 392455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1