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

Model Number 57063/9207010

Device Problems Sparking (2595); Protective Measures Problem (3015)

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

Event Date 01/07/2015

Event Type  malfunction  

Event Description

The customer reported that she saw sparking from the housing of her pump in style transformer.Upon inspection and product evaluation on (b)(6) 2015, a breach was discovered, which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.A product evaluation on (b)(6) 2015 confirmed the customer's complaint.Evidence of sparking was found on the internal components.During the product evaluation, a breach was found in the transformer housing, which is a safety risk.A visual examination of the power supply revealed the transformer housing was breached, exposing inner electrical circuitry.It also found evidence of sparking on the internal electronics.A visual examination of the cord revealed nothing unusual.The power supply was not plugged in for safety reasons.Resistance across the dc plug was measured as 107k ohms, which indicates that there is not a short in the dc cord.The resistance across the ac blades measures as 54.6 ohms, which is normal and indicates that the thermal fuse did not blow.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 forseeable 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.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.

• 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 60050-7005 ; 8004358316
• MDR Report Key: 4479641
• MDR Text Key: 5346668
• Report Number: 1419937-2015-00030
• 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: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• 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: 3912/REV M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2015
• 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