MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number	57081
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement power supply was sent to the customer.The issue with a damaged rev p power supply for the pump in style device is currently being evaluated under an investigation for (b)(4).A conclusion regarding this issue cannot be made at this time.
Event or Problem Description
On (b)(6) 2017, the customer alleged to medela llc that the "casing" for the power supply for her pump in style breast pump came apart, exposing wires.
Additional Manufacturer Narrative
The issue with a damaged pump in style rev p power supply for the pump in style device was evaluated under an investigation for complaint category (b)(4), which found that breaches in the rev p power supply housing are the result of an external large force impact and are not the result of a malfunction.

• Brand Name: BREASTPUMP PNSA STARTER
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 7149265
• Report Number: 1419937-2017-00365
• Device Sequence Number: 786277
• Product Code: HGX
• UDI-Device Identifier: 00020451570815
• UDI-Public: 00020451570815
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K031614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 57081
• Device Catalogue Number: 57081
• Device Lot Number: REV P 1636C
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/04/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1