MAUDE Adverse Event Report: MEDELA, INC PUMP IN STYLE (ITEN # UNK)

Model Number UNK / 9207010

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

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

Event Date 01/05/2015

Event Type  malfunction  

Event Description

The customer reported that there were exposed wires on his wife's pump in style power adapter and that there was sparking from the base of the transformer housing, which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.In follow up with the customer, the customer stated that the original power supply had been shipped.As of the date of this report, the original power supply has not been received.Should the original power supply be received resulting in new, changed, or corrected information, a follow up 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 (ITEN # UNK)
• Manufacturer (Section D): MEDELA, INC; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4482286
• MDR Text Key: 5566897
• Report Number: 1419937-2015-00031
• 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: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK / 9207010
• Device Catalogue Number: UNK / 9207010
• Device Lot Number: 131 / PRIOR TO REV L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/05/2015
• Date Manufacturer 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