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

Model Number 57063/207010

Device Problems Degraded (1153); Sparking (2595); Fail-Safe Problem (2936)

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

Event Date 04/21/2014

Event Type  malfunction  

Event Description

Customer called in to report that her transformer had exposed wires on cord and she saw sparking.

Manufacturer Narrative

A replacement power adapter was sent to the customer and request the defective power adapter be returned for eval.In f/u with the customer, she indicated that she did get a small shock from the exposed wires, however, there was no medical treatment involved.The product involved in the complaint was not returned for eval/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 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, medela 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 GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3972855
• MDR Text Key: 4748462
• Report Number: 1419937-2014-00391
• 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: 04/21/2014

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: 57063/207010
• Device Catalogue Number: 57063/9207010
• Device Lot Number: PRIOR TO REV L-1115A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2014
• 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