MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number	101041360/101029653
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement battery pack was sent to the customer.The customer indicated she disposed of the original battery pack so it was not available for return and investigation.In follow up with a complaint handler on 07/05/2022, the customer indicated she was smelling gas in her home.She thought it was the stove or coming from her garage but the smell lead her to her pump bag.She indicated there was no leakage, just a strong smell where batteries were located.In further follow up with the customer for additional information on 07/06/2022, she stated the batter pack caught on fire and she saw flames.
Event or Problem Description
On 6/30/2022, the customer alleged to medela llc she noticed an electrical odor coming from her backpack which contained her unplugged pump in style maxflow battery pack.She also alleged to have seen flames coming from the battery pack.

• Brand Name: PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 14999877
• Report Number: 1419937-2022-00059
• Device Sequence Number: 1614195
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• 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): 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 101041360/101029653
• Device Catalogue Number: 101041360/101029653
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/30/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/13/2022
• Date Device Manufactured: 04/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female