MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO JOEY, PUMP W/ POLE CLMP; FEEDING PUMP

Model Number 383400

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 07/18/2014

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 during testing, spark occurred from the plug and the battery could not be charged.No patient involvement.

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.During review of the unit, the reported condition by the customer was duplicated.The contact failure of the power cable was confirmed and replaced.There was no spark or burn mark confirmed on the unit.The gearbox cleaning was then performed.The connection of the power cable and the unit was loose and the connector was replaced.Based on the investigation no corrective and preventative action will be taken at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: KANGAROO JOEY, PUMP W/ POLE CLMP
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crescent; singapore 0000 ; SG 0000
• Manufacturer (Section G): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4041004
• MDR Text Key: 17280660
• Report Number: 3009247326-2014-00015
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer 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