MAUDE Adverse Event Report: MEDELA AG SYMPHONY PLUS RENTAL; PUMP, BREAST, POWERED

Model Number	01526
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint handler followed up with the customer (b)(6) 2022.And she stated that she had been using the symphony pump since (b)(6) a few times a day.At the time of the incident she said she was not in the room where it was plugged in and then her husband called her because he smelled something.She did not see any fire and she indicated that she did not have any issues with her outlet that she is aware of.Additionally she stated that there was no heater by the pump.The device was evaluated on 4/13/2022.It was determined that the housing was melted and charred.It was also noted that all the internal printed circuit boards (pcb's) were functional.A portion of the power cord had melted but was functional.All charring and melting indicates an external heat source but this could not be verified by the customer.The pump was functional and able to be tested and passed the power test and passed the suction and cycle specifications.
Event or Problem Description
On (b)(6) 2022, a medela account called and alleged that a customer brought a symphony breast pump in and said that it sparked and caught on fire.The unit was showing signs of burning on one side and it was replaced for the customer.

• Brand Name: SYMPHONY PLUS RENTAL
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 14166517
• Report Number: 3002807523-2022-00005
• Device Sequence Number: 11981480
• Product Code: HGX
• UDI-Device Identifier: 00020451242156
• UDI-Public: 020451242156
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 01526
• Device Catalogue Number: 01526
• Device Lot Number: 0000036274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Distributor Facility Aware Date: 04/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female