MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number 57063

Device Problems Crack (1135); Fire (1245); Smoking (1585)

Patient Problem No Information (3190)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

A replacement power supply was sent to the customer.Multiple attempts to follow up with the customer to get additional information went unanswered.This issue with a damaged rev m power supply for the pump in style device was addressed in investigation (b)(4).The investigation found that they were being damaged during shipment from the manufacturer to medela.This damage was causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the power supply to medela was not robust enough to handle all of the potential shipping, handling, and abuse conditions that could arise from logistics of the consolidation process.As a result of the investigation, the shipping and consolidation process was modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength was also increased to further protect the power supply during shipping.Since then, as a part of routine continuous improvement activities, a rev p power supply has been distributed to market, manufactured under a revised design and by a different manufacturer.

Event Description

On (b)(6) 2017, the customer alleged to medela llc that when she plugged her pump in style power supply into the wall, she saw a flame and smoke came out.She indicated that the power supply housing was cracked and she can see inside.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7086477
• MDR Text Key: 94079569
• Report Number: 1419937-2017-00343
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K031614
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 9207010 REV M
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/08/2017
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/06/2017
• 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