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

Model Number 57063/9207010

Device Problems Crack (1135); Material Integrity Problem (2978); Protective Measures Problem (3015)

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

Event Date 03/27/2015

Event Type  malfunction  

Event Description

The customer reported that the housing for her pump in style power adapter was cracked and the inner electronics were exposed, which is safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.In follow-up wit the customer, she reported that her transformer housing had a hole in it and that she could see the inner circuitry.She said that when she took the adapter out of the wall, it fel apart and a piece fell off the top.She was able to snap it back together, but there is still a hole at the top.The customer also said that she received the replacement power adapter and that she will return the original power adapter.As of the date of this report, the original power adapter has not been received.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.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4680272
• MDR Text Key: 5692299
• Report Number: 1419937-2015-00108
• 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: 04/07/2015

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: 2011/REV L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/09/2015
• 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