MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE (ITEM #UNK)

Model Number 57XXX/9207010

Device Problem Sparking (2595)

Patient Problem No Information (3190)

Event Date 02/27/2014

Event Type  malfunction  

Event Description

Customer called in to report that her power source wiring is sparking from her pump in style transformer.

Manufacturer Narrative

A replacement power supply was sent to the customer.Attempts to follow up with the customer to get additional complaint information and to the product back including a final attempt by letter were unsuccessful.As of the date of this report the product has not been received.The customer reported sparking from exposed wired on her pump in style power adapter.On 4/4/2011, 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 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.Should additional information or the original product be received, resulting in new, changed or correct information, a follow up report will be filled at that time.

• Brand Name: PUMP IN STYLE (ITEM #UNK)
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3807615
• MDR Text Key: 4371867
• Report Number: 1419937-2014-00287
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• 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: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57XXX/9207010
• Device Catalogue Number: 57XXX/9207010
• Device Lot Number: PRIOR TO REV L -UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• 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