MAUDE Adverse Event Report: AMEDA, INC. FINESSE; ELECTRIC BREAST PUMP

Model Number 4100018

Device Problem Sparking (2595)

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

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Returned ac adapter has a visible crack around damaged prong location.Not a manufacturing defect/issue.Communication log information states "using the pump for 7 months, pumping 5 times/day" and "admits that the ac adapter has gotten cracked at some point in time and has exposed components." no exposed components were visible on returned ac adapter.Faint odor of an electronic component failure/thermal event noticed.Returned ac adapter 120v housing was disassembled, very minor charring observed in location on top side of pcb, above area of damaged prong on the pcb.Charring is evident around damaged prong/pcb connection location where thermal event occurred.Communication log information states "using the pump for 7 months, pumping 5 times/day" and "admits that the ac adapter has gotten cracked at some point in time and has exposed components." unable to determine the fault of ac adapter failure/damage.Ac adapter was not tested citing safety concerns.

Event Description

Customer contacted ameda, inc.To report the ac adapter she uses to power on her finesse breast pump sparked in the middle of a pumping session.She states the ac adapter is ameda branded and came to her with the breast pump base.Customer states no injury occurred in this event.She did admit the ac adapter was physically broken and she should have stopped using it when she noted the damage.She reports the adapter was delivered intact around (b)(6) 2019 and only recently became damaged due to a fault of her own.A replacement ac adapter was shipped to this customer.

• Brand Name: FINESSE
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 485 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 9415940
• MDR Text Key: 190201099
• Report Number: 3009974348-2019-00346
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725023563
• UDI-Public: (01)00810725023563(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/05/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: 4100018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR