MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number	57063
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement power supply was sent to the customer and return of her original power supply was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2019, the customer indicated the power supply housing came apart and smelled like fire when she tried to remove it from the wall outlet.Additionally, she indicated the burn from touching the hot power supply did not require medical treatment.The issue with a damaged rev n power supply for the pump in style device was addressed in investigation (b)(4), which was trended as part of the effectiveness check for (b)(4), which found that the power supplies were being damaged during shipment from the manufacturer to medela.As a part of routine continuous improvement activities, the rev n power supply was replaced with a rev p power supply, manufactured under a revised design and by a different manufacturer.
Event or Problem Description
On (b)(6) 2019, the customer alleged to medela llc that the power supply for her pump in style breast pump had an electrical smoke odor and the housing had broken apart.She additionally alleged that the power supply was hot and burned her finger when she touched it.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• MDR Report Key: 8418013
• Report Number: 1419937-2019-00036
• Device Sequence Number: 16536921
• Product Code: HGX
• UDI-Device Identifier: 00020451570631
• UDI-Public: 00020451570631
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 9207010 REV N/2413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1