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

Model Number 4100018

Device Problem Fire (1245)

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

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The product involved in the complaint was not returned for investigation at this time despite 3 follow up messages to the customer.Therefore, no conclusions can be made as to the cause or the event.Should additional information or the original product be received resulting in new, changed or corrected information, a follow-up report will be filed at that time.

Event Description

Customer contacted ameda, inc.On 02/24/2020 to report the finesse pump she uses stopped functioning properly on friday (b)(6) 2020 when she prepared to pump at home.She usually plugs the ac adapter into one of the electrical outlets at home and starts pump operating before placing it to her breasts.She had momentarily walked away from the pump and when she returned, she saw sparking from the ac adapter end in the electrical outlet.She then saw the black casing above the prongs break apart and burst into flames.Mom quickly pulled the cord out of the outlet.Flames died out and sparking stopped.Mom reports no injury to herself or others in the house.Mom reports pump will not power on with batteries.A replacement finesse pump and ac adapter was shipped overnight to customer.

Manufacturer Narrative

Ac adapter transformer housing severely damaged (broken into 3 parts, top, back, and pc board component), and prongs connected to pc board are damaged at pcb connection area.There is no evidence or indication that supports the allegation that this returned ac adapter "burst into flames".Condition of returned pump and ac adapter damage does not indicate or support that this is a manufacturing issue.

• Brand Name: FINESSE
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA.COM; 485 half day rd.; suite 320; buffalo grove, il
• MDR Report Key: 9874478
• MDR Text Key: 184743909
• Report Number: 3009974348-2020-00350
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725023563
• UDI-Public: (01)00810725023563(21)
• Combination Product (y/n): N
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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: 03/25/2020
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR