MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ORIGINAL BREAST PUMP

Model Number UNK/9207010

Device Problem Sparking (2595)

Patient Problem No Information (3190)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

Customer reported to customer service that the transformer wires pump in style breast pump were exposed and had sparked.This is a safety risk.

Manufacturer Narrative

The customer reported that her transformer had exposed wires and had sparked.She did not report of any injuries or fire.The customer also stated she had discarded the defective product and will not be sending the product in for evaluation.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.The customer reported sparking from exposed wires on her pump in style power adapter.On (b)(6) 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 a 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, medela has updated 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 (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 management for investigation/capa consideration.

• Brand Name: PUMP IN STYLE ORIGINAL BREAST PUMP
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3721226
• MDR Text Key: 4269282
• Report Number: 1419937-2014-00267
• 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: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK/9207010
• Device Catalogue Number: UNK/9207010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/03/2014
• Date Manufacturer Received: 03/03/2014
• 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