MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE (ITEM # UNK)

Model Number UNK/9207010

Device Problems Overheating of Device (1437); Sparking (2595)

Patient Problem No Information (3190)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

The customer reported that when she went to unplug her pump in style power adapter, a blue spark came from the transformer housing and the power adapter was hot to the touch when she went to remove it from the wall outlet.

Manufacturer Narrative

The customer's report of a spark coming from the housing of her power adapter is a safety issue.In f/u with the customer, the customer stated that there were no injuries that resulted and that she discarded the power adapter.As a result of capa (b)(4) which was initiated for pump in style transformer overheating/melting issues, a field action safety notification was initiated on 04/04/2011.Activities related to this notification are on-going.

• Brand Name: PUMP IN STYLE (ITEM # UNK)
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3843571
• MDR Text Key: 4656064
• Report Number: 1419937-2014-00295
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK/9207010
• Device Catalogue Number: UNK/9207010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/10/2014
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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