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

Model Number 57063/9207010

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

The customer's mother reported to customer service that she saw sparking at the prongs.When the transformer was received back at medela it was determined to be breached on (b)(6) 2014.

Manufacturer Narrative

A replacement transformer was sent to the customer.The product involved in the complaint was returned on (b)(6) 2014 and evaluated on (b)(6) 2014.The customer's complaint sparking was not confirmed, however the product evaluation showed that the transformer housing was breached.The cause of the breach in the rev n transformer has not been determined at this time.It is currently being investigated under (b)(4).A visual examination of the power supply revealed the transformer housing was breached, exposing inner electrical circuitry.A visual examination of the cord revealed no exposed wires.The power supply was plugged in and the voltage output across the dc plug was measured as 0 vdc.Resistance across the dc plug measured 0.74m ohms, which indicates that there is not a short in the dc cord.The resistance across the ac blades measured open, and indicates that thermal fuse did blow.Smoke, fire and sparking was not observed while plugged in.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4137875
• MDR Text Key: 4794576
• Report Number: 1419937-2014-00750
• 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: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57063/9207010
• Device Catalogue Number: 57063/9207010
• Device Lot Number: REV N -3113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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