MAUDE Adverse Event Report: MEDELA, INC. BP ADVANCED PERSONAL DOUBLE; HGX

Model Number 9207010/57065

Device Problem Sparking (2595)

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

Event Date 11/17/2014

Event Type  malfunction  

Event Description

The customer reported to customer service that the transformer wires of her advanced personal double breast pump had sparked which is a safety risk.

Manufacturer Narrative

The customer reported sparking from exposed wires on the transformer.She did not report of any injury or fire.Product was received and evaluated on 12/03/2014 by qe.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.A visual examination of the cord revealed there were exposed wires on cord near base of housing and the cord was twisted.The power supply was unsafe to plug in so the voltage across the dc plug was not measured.Resistance across the ac blades measured as 58.2 ohms, which is normal and indicates that the thermal fuse did not blow.

• Brand Name: BP ADVANCED PERSONAL DOUBLE
• 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: 4339924
• MDR Text Key: 16542940
• Report Number: 1419937-2014-00906
• 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: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010/57065
• Device Catalogue Number: 9207010/57065
• Device Lot Number: PRIOR TO REV L/1111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2014
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1