MAUDE Adverse Event Report: MEDELA, AG FREESTYLE HANDS FREE

Model Number 67060/9207047

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Information (3190)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

The customer reported to medela customer svc that the freestyle power adapter started sparking and caused small fire.

Manufacturer Narrative

A replacement breast pump was sent to the customer and requested the defective breast pump be returned for eval.The defective breast pump has not been received at medela as of 09/17/2014.The product involved in the complaint was not returned for eval/investigation.Therefore, no conclusion can be made as to the cause of the event.Customer f/u was not successful.Should add'l info or the original product be received, resulting in new, changed or corrected info, a f/u report will be filed at that time.This issue with fire for the freestyle power adapter is currently being addressed in investigation (b)(4).

• Brand Name: FREESTYLE HANDS FREE
• Manufacturer (Section D): MEDELA, AG; baar 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA, AG; lattichstrasse 4 b; baar 6341 ; SZ 6341
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4115543
• MDR Text Key: 4700649
• Report Number: 1419937-2014-00724
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/10/2014,09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 67060/9207047
• Device Catalogue Number: 67060/9207047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/10/2014
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1