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

Model Number 57063-9207010

Device Problems Smoking (1585); Split (2537); Sparking (2595)

Patient Problem No Information (3190)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

The customer reported to customer service that the transformer housing split apart exposing internal wires, sparked and was smoke.

Manufacturer Narrative

A replacement power supply was sent to the customer.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.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.The cause of the breach in the rev n transformer has not been determined at this time.It is currently being investigated under (b)(4).

• Brand Name: PUMP INSTYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004359316
• MDR Report Key: 3868486
• MDR Text Key: 4566999
• Report Number: 1419937-2014-00404
• 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: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• 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: REV N-3113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/28/2014
• Date Manufacturer Received: 04/28/2014
• 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