MAUDE Adverse Event Report: COVIDIEN RFB KANGAROO EPUMP; ENTERAL FEEDING PUMP

Model Number DL482400J

Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913); Electronic Property Issue (2928)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/07/2016.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 pump.The customer reports that after priming the pump, it will shut down by itself and won't turn on again.No patient involvement or harm.

Manufacturer Narrative

Submit date: 10/25/2016.An investigation of kangaroo epump was performed for the reported condition of; the unit will shut down by itself and won¿t turn on again.The unit was triaged and the complaint was confirmed.The cause of the reported condition was due to failure of the unit¿s pcb; the pcb was replaced to correct the issue.The unit was then fully tested; unit passed all testing.The unit was manufactured in 2013.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: RFB KANGAROO EPUMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5703206
• MDR Text Key: 48016290
• Report Number: 1282497-2016-00310
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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: DL482400J
• Device Catalogue Number: DL482400J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• 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