MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

Model Number 57062/9207010

Device Problems Crack (1135); Sparking (2595)

Patient Problem No Information (3190)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

Customer reported that the transformer sparked when pulled out from the wall and the housing was cracked and she could see exposed wires which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.In follow up with the customer she stated that parts of the plastic housing cracked and fell away from the unit and she could see exposed wires which is a safety risk.She confirmed that there was no injury from the event.No smoke or fire, but there was a spark when she pulled the unit from the wall at the prongs.This issue with the damaged transformer housing for the pump in style device was addressed in investigation (b)(4).The investigation found that the transformers are being damaged during shipment from the manufacturer to medela.This damage is causing the plastic housing to fall prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the transformers to medela is 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 has been modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength has also been increased to further protect the transformers during shipping.This corrective action applies to transformers with a date code greater than or equal to 3912.Complaint data trending will continue to be monitored by medela quality management for investigation/capa consideration.Possibility resolutions provided to customer: replacement product or online ordering information.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004355316
• MDR Report Key: 3888121
• MDR Text Key: 20104141
• Report Number: 1419937-2014-00374
• 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: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57062/9207010
• Device Catalogue Number: 57062/9207010
• Device Lot Number: REV L - 1811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1