MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE ADVANCE BREAST PUMP GO TOTE; HGX

Model Number 57063/9207010

Device Problems Crack (1135); Protective Measures Problem (3015)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The customer originally reported to customer service that the transformer housing for her pns was cracked, but not coming apart.Upon receipt at medela the transformer was inspected and found to be breached, which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.Upon receipt of the product an evaluation showed that the housing was breached, exposing internal electronics, which is a safety risk.Per qe evaluation, the transformer housing appears to have been broken and repaired by the end user.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 fail 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.Evaluation summary: a visual examination of the power supply revealed the transformer housing was breached, exposing inner electrical circuitry.A visual examination of the cord revealed nothing unusual.The voltage across the dc plus was not available.The transformer was unsafe to plug in.The resistance across the ac blades measured as 54.4 ohms, which is normal and indicates that the thermal fuse did not blow.Resistance across the dc plug was measured open, which indicates that there is not a short in the dc cord.

• Brand Name: PUMP IN STYLE ADVANCE BREAST PUMP GO TOTE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4374485
• MDR Text Key: 17946548
• Report Number: 1419937-2014-00936
• 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: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 L-0912
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/24/2014
• 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