MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO EPUMP - NEW; FEEDING PUMP

Model Number 382400

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a feeding pump.The customer states that the power supply almost caught fire, it sparked and there was smoke.There was melted plastic around the power adapter.The customer had just put the pump on the pt, they were in the room with the pt and the outlet and power supply started to spark and smoke.The nurse grabbed this and pulled it out of the wall.This was starting to burn but never actually caught fire, there were no flames.The customer had to put enough pressure on the adapter to pop it off and they could see that pieces were melted together.No harm to the pt.The pump was still connected to the pt running off of the battery.They had to disconnect the pump from the pt.

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway, upon completion, the results will be forwarded.

Manufacturer Narrative

A review of the device history records shows this device was released meeting all manufacturing specifications.One kangaroo epump adp w/ 4 pwr adp plg was returned to the service department with a specific request for service/repair.The unit was escalated to a senior technician where it passed all functional and recertification testing, therefore; this reported issue could not be confirmed.The pump shows no signs of burn or smoke damage as a result of the power adapter.The power adapter in question was not received with the pump.The pump will be serviced and returned to stock.Without the power adapter sample to investigate, no actual root cause can be determined, though the most likely root cause would be an internal component failure within the power adapter.The product kangaroo epump - new was manufactured in 2009.Without a sample provided, we are unable to determine the year of manufacture for the power adapter.A review of the service history records indicates there is no other service history recorded for this system.If additional information is obtained, or the sample is returned to the service department, we will re-open this investigation.This complaint will be recorded for tracking and trending purposes.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crescent; singapore ; SG
• Manufacturer (Section G): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore 0000 ; SN 0000
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4094950
• MDR Text Key: 4840733
• Report Number: 3009247326-2014-00013
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/14/2014

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: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 07/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2014
• 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