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U.S. Department of Health and Human Services

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

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AMEDA, INC. FINESSE ELECTRIC BREAST PUMP Back to Search Results
Model Number 4100018
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/24/2019
Event Type  Malfunction  
Manufacturer Narrative

The returned finesse pump was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed. It was assessed for indications of malfunction or thermal event. It was also assessed for functionality and met functional specifications. Internally, there were no indications of burning, melting or charring visible. Evidence supports user error was the result of battery failure.

 
Event Description

Customer contacted ameda, inc. On (b)(6) 2019 to report an incident in which the batteries installed inside the finesse battery compartment may have leaked a thick white fluid in the right corner of the compartment. She states she leaves batteries inside the battery compartment in the event she wants to switch power modes from ac adapter to battery use. These batteries were left inside the compartment for 3 days while she used the ac adapter. Customer states the batteries appeared intact but never functioned. Customer failed to remove the batteries that were never functional. She did not come in contact with the fluid and states no harm. Customer was overnight shipped a replacement finesse breast pump to resolve this issue.

 
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Brand NameFINESSE
Type of DeviceELECTRIC 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 Key8523392
MDR Text Key145788883
Report Number3009974348-2019-00338
Device Sequence Number1
Product Code HGX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK973501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 03/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number4100018
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/11/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/03/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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