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

Model Number 9207010/57063

Device Problem Break (1069)

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

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

A replacement transformer was sent to the customer.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusion 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 ir (b)(4).

Event Description

The customer reported to customer service that the transformer housing for her pump in style advanced breastpump was broken and she could see exposed wires, which is a safety risk.

Manufacturer Narrative

The pump in style transformer was returned to medela and evaluated.There was no damage to the transformer housing as reported by the customer, however it was noted on the evaluation that the power cord had exposed wires.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 5258470
• MDR Text Key: 32579164
• Report Number: 1419937-2015-00344
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010/57063
• Device Catalogue Number: 9207010/57063
• Device Lot Number: REV M/LOT 4112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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