MAUDE Adverse Event Report: JABIL SINGAPORE KANG EPMP ADP W/ 4 PWR ADP PLG; E-PUMP POWER ADAPTER

Model Number 382491

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with an e-pump power adapter.The customer reports that the ac adapter was sent to biomed due to melted plastic housing on unit located near plug prongs.No patient involved.

Manufacturer Narrative

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

• Brand Name: KANG EPMP ADP W/ 4 PWR ADP PLG
• Type of Device: E-PUMP POWER ADAPTER
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crescent; singapore 0000 ; SN 0000
• Manufacturer (Section G): SABIL SINGAPORE; 16 tampines industrial crescent; singapore ; SN
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3823662
• MDR Text Key: 16600088
• Report Number: 3009247326-2014-00005
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382491
• Device Catalogue Number: 382491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1