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

Model Number 57027/9207010

Device Problem Sparking (2595)

Patient Problem No Information (3190)

Event Date 04/18/2014

Event Type  malfunction  

Event Description

Mom stated that the power adapter was sparking from the exposed wires.

Manufacturer Narrative

A replacement power adapter was sent to the customer and request the defective power adapter be returned for eval.The product involved in the complaint for eval/investigation was disposed by the customer.Therefore, no conclusion can be made as to the cause of the event.In f/u with the customer, she indicated that the power cord was sparking from exposed wires.She pumps two times a day and plugs in/out the transformer about two times a day.She indicated that she did not witness any fire or flame and that no injuries were sustained as a result of the issue.The customer reported sparking from exposed wires on her pump in style power adapter.On 04/04/2011, medela issued a pump in style power adapter safety notification.The safety notification was the result of the findings of capa (b)(4), which addressed issues with exposed wires and found the probable root cause to be degradation of the insulation separating the positive and negative wires.The probable causes of the degradation of the insulation have been attributed to the cord being wrapped around the transformer housing and/or being pulled from the outlet by the cord instead of by the transformer housing.As a result, customers were informed not to wrap the cord around the transformer to prevent damage and to discontinue use of any transformer that appears damaged.In addition, madela has upgraded the cord and the transformer material has been changed to a more heat stable material.The updated transformer also contains both electrical and heat thermal fuses so that in the event of a failure, the transformer will fail safe.The subject unit was manufactured prior to the corrective action under ca (b)(4).The customer was either provided with a replacement transformer or referred to an ordering source to resolve this issue.No further action is required.Complaint data trending will continue to be monitored by medela quality mgmt for investigation/capa consideration.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3972868
• MDR Text Key: 15815903
• Report Number: 1419937-2014-00389
• 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: 04/18/2014,04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57027/9207010
• Device Catalogue Number: 57027/9207010
• Device Lot Number: PRIOR TO REV L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/18/2014
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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