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

Model Number 24502082

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Returned ac adapter, p/n 4100103, model dys612-090130w-1 lot 2819 has visible damage to prongs (bent upward) and above prong location 120v housing, which is missing a significant section.Faint odor of an electronic component failure/thermal event noticed.Returned ac adapter, p/n 4100103, model dys612-090130w-1 lot 2819 housing was then opened for internal investigation.Removed ac adapter pcb to inspect both sides of pcb where damaged prong is connected/located.Minor charring is evident around damaged prong/pcb connection location where thermal event occurred.Engineering conclusion evidence does not support an explosive event.Damage to the prongs and their connection to the pcb indicates that the ac adapter most likely sustained damage prior to the "spark" event.Unable to determine the fault of ac adapter failure/damage.Testing of returned finesse pump was waived due to communication log indicating the pump still functions.Preliminary inspection of returned finesse p/n #4100018, s/n# (b)(4) /sw meets specifications.

Event Description

Customer contacted ameda, inc.On (b)(6) 2020 to report an event that occurred recently when using the finesse pump with the ameda ac adapter.Customer has been pumping for 5 months up to 4 times/day.She initially reports hearing a "ticking" sound coming from the ac adapter.Upon subsequent use, she said the ac adapter felt warm to the touch.Following a few more uses, she said the ac adapter "sparked and seemed to fall apart".She says the pump will still work, but she is very concerned.Customer was instructed not to use this pump any longer.A replacement finesse and ac adapter was shipped overnight to the 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: 10693254
• MDR Text Key: 240174628
• Report Number: 3009974348-2020-00353
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24502082
• Device Lot Number: 2819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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: 24 YR