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

Model Number 392455

Device Problem Device Stops Intermittently (1599)

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 (b)(6) 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 unit¿s battery.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
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shgnahi ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5692501
• MDR Text Key: 47354481
• Report Number: 1282497-2016-00284
• 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

• Date FDA Received: 06/01/2016
• 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
• Date Manufacturer 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