MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

Model Number 57063/9207010

Device Problem Sparking (2595)

Patient Problem No Information (3190)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The customer reported to customer service that her pump in style transformer has exposed wires.She also reported that the wires sparked at he exposed wires near the housing, which is a safety risk.

Manufacturer Narrative

A replacement adapter was sent to the customer.As a result of capa (b)(4) which was initiated for pump in style transformer overheating/melting issues, a field action safety notification was initiated on (b)(6) 2011.Activities related to this notification are on-going.The product involved in the complaint was not returned for eval/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.Attempts to retrieve the product are on going.Should add'l info or the original product be received, resulting in new, changed, or corrected info, a follow up report will be filed at that time.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4436375
• MDR Text Key: 5312917
• Report Number: 1419937-2015-00017
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57063/9207010
• Device Catalogue Number: 57063/9207010
• Device Lot Number: 1114G PRIOR TO REV L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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