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

Model Number 101041360/101029653

Device Problems Fire (1245); Device Emits Odor (1425)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2022

Event Type  malfunction  

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 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)
• Type of Device: 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
• MDR Text Key: 295781676
• Report Number: 1419937-2022-00059
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451401454
• UDI-Public: 020451401454
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 06/30/2022
• Date Device Manufactured: 04/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female