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

Model Number 57063/9207010

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

The customer reported to medela customer service that her pump in style transformer housing cracked open exposing inner electrical circuitry, which is a safety risk.

Manufacturer Narrative

A replacement power adapter was sent to the customer and requested the defective power adapter be returned for evaluation.The defective power adapter has not been received at medela as of 2/2/15.The product involved in the complaint was not returned for evaluation/investigation.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.This issue with a damaged rev n transformer housing for the pump in style device is currently being addressed in ir13-0154.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4491498
• MDR Text Key: 5347448
• Report Number: 1419937-2015-00035
• 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: 01/30/2015,02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3113 REV N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/30/2015
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/05/2015
• 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