MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO EPUMP - NEW

Model Number 382400

Device Problem Charred (1086)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, an updated investigation will be provided.

Event Description

It was reported to medtronic on (b)(6) 2015 that a customer had an issue with an epump.The customer states the power cord used with the pump was charred at the end; on the metal receptors that go into the wall outlets.

Manufacturer Narrative

Investigation: 10/28/2015.An investigation of kangaroo epump was performed for the reported condition of, ¿customer reported that the power cord used with the pump was charred at the end; on the metal receptors that go into the wall outlets.¿ initial testing of the unit found that the ac adapter failed output testing therefore; this report will be considered confirmed.The ac adapter was defective causing it to fail output testing.The pump and ac adapter have been repaired and returned to the customer.Kangaroo epump was manufactured in 2012.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: EPUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer (Section G): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4951749
• MDR Text Key: 23221928
• Report Number: 1282497-2015-00034
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• 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