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 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

The returned finesse breast pump could not be tested using returned damaged ac adapter from customer citing safety issues.The returned finesse could not be tested for functionality with the loose dial issue.The pump housing was opened and the pump was visually inspected for damage.Upon visual inspection of internal components, the speed and suction pcb contacts were worn,.Minor pulley belt dust was observed inside the pump housing.Milk residue was also observed in piston housing and on back side of pcb.

Event Description

Customer contacted ameda, inc.On (b)(6) 2019 to report that while using her finesse breast pump the night before, she smelled an electrical burning odor coming from the breast pump.Customer states sparks were emitted from the ac adapter port side of the breast pump.She did not see any flames or smoke.She states no injury when this event occurred.A replacement pump base and ac adapter were overnight shipped 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: 8422920
• MDR Text Key: 139429391
• Report Number: 3009974348-2019-00336
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• 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: 03/14/2019
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2018
• 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: 32 YR