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

Model Number 57063/9207010

Device Problems Device Inoperable (1663); Temperature Problem (3022)

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

Event Date 12/17/2013

Event Type  malfunction  

Event Description

The customer reported the power adapter gets really hot and no longer works.During the product evaluation, the technician observed a breached transformer housing, which is a safety risk.

Manufacturer Narrative

A replacement power adapter was sent to the customer and requested the defective power cord as the technician was unable to be returned for eval.The defective power cord was received at medela on 12/31/2013.A product eval was unable to confirm nor refute the customer reported problem as the technician was unable to perform the voltage across the dc plug test due to prongs being out of position.The product eval also revealed the transformer housing was cracked open, exposing inner electrical circuitry which is a safety risk.The issue with a breached transformer housing for the pump in style device is currently being addressed under investigation (b)(4).Evaluation summary: a visual examination of the power supply revealed the transformer housing was cracked open, exposing inner electrical circuitry.A visual examination of the cord revealed nothing unusual.The technician was unable to perform voltage across the dc plug test due to prongs being out of position.Resistance across the dc plug was measured open, which indicates that there is not a short in the dc cord.The resistance across the ac blades measured as 21.60 ohms, which is normal and indicated that the thermal fuse did not blow.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3788722
• MDR Text Key: 4384852
• Report Number: 1419937-2014-00096
• 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: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• 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: 59063/9207010
• Device Lot Number: 1313 REV N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/31/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2014
• 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