MAUDE Adverse Event Report: MEDELA LLC ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK); PUMP, BREAST, POWERED

Model Number	57018W
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer refused to return the power supply for testing/evaluation and customer service provided the customer with information regarding how to purchase a replacement power supply.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 her pump in style breast pump power supply had broken apart during storage.

• Brand Name: ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• MDR Report Key: 8418057
• Report Number: 1419937-2019-00038
• Device Sequence Number: 11242989
• Product Code: HGX
• UDI-Device Identifier: 00020451570181
• UDI-Public: 00020451570181
• Combination Product (Y/N): N
• 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: 57018W
• Device Catalogue Number: 57018W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• 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