MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE (ITEM # UNK); HGX

Model Number 9207010/57XXX

Device Problems Detachment Of Device Component (1104); Fire (1245); Melted (1385); Sparking (2595)

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

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

A replacement power supply was sent to the customer.The customer responded to a follow-up contact via email on (b)(6) 2015.The customer provided the power adapter lot and date code information at this time.She also confirmed that when she unplugged the power adapter, it fell apart and sparked, causing a napkin that was on her desk to catch fire.She stated in her email that she would return the damaged product.As of the date of this report, the original product has not been received.Should the original device be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.This issue with the damaged transformer housing for the pump in style device was addressed in investigation (b)(4).The investigation found that the transformers are being damaged during shipment from the manufacturer to medela.This damage is causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the transformers to medela is not robust enough to handle all of the potential shipping, handling, and abuse conditions that could arise from logistics of the consolidation process.As a result of the investigation, the shipping and consolidation process has been modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength has also been increased to further protect the transformers during shipping.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.

Event Description

The customer reported that when she unplugged the power adapter for her pump in style breast pump, the cover came off the adapter and the adapter started sparking.The spark lit a napkin that was on her desk on fire, which is a safety risk.She did put out the fire.When she unplugged the power adapter, the parts were melted and scorched.

• Brand Name: PUMP IN STYLE (ITEM # UNK)
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 5099116
• MDR Text Key: 26834700
• Report Number: 1419937-2015-00276
• Device Sequence Number: 0
• Product Code: HGX
• 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: Patient
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010/57XXX
• Device Catalogue Number: 9207010/57XXX
• Device Lot Number: REV L-1511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1