MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ORIGINAL BREAST PUMP; HGX

Model Number 57040/9207010

Device Problems Sparking (2595); Scratched Material (3020)

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

Event Date 12/22/2014

Event Type  malfunction  

Event Description

The customer reported to customer service that her pump in style transformer has exposed wires.She also reported that there was sparking from the exposed wires, which is a safety risk.

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 info or the original product be received, resulting in new changed, or corrected info a f/u report will be filed at that time.As a result of capa (b)(4) which was initiated for pump in style transformer overheating/melting issues, a field action safety notification was initiated on 04/04/2011.Activities related to this notification are on-going.

• Brand Name: PUMP IN STYLE ORIGINAL BREAST PUMP
• Type of Device: HGX
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4384444
• MDR Text Key: 18090795
• Report Number: 1419937-2014-00941
• 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: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57040/9207010
• Device Catalogue Number: 57040/9207010
• Device Lot Number: PRIOR TO REV L-12K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/22/2014
• Date Manufacturer Received: 12/22/2014
• 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