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

Model Number 9207041/57XXX

Device Problems Crack (1135); Protective Measures Problem (3015)

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

Event Date 12/09/2014

Event Type  malfunction  

Event Description

The customer reported to customer service that the transformer housing of her pump in style breast pump was cracked exposing the underlying electronics which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.The customer reported a breach in the transformer housing.She did not report any fire, spark or injury.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.The cause of the breach in the 9207041 transformer has not been determined at this time.This issue is currently being investigated under (b)(4).

• Brand Name: PUMP IN STYLE (ITEM # UNK)
• Type of Device: HGX
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4384460
• MDR Text Key: 15314906
• Report Number: 1419937-2014-00939
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207041/57XXX
• Device Catalogue Number: 9207041/57XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/09/2014
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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