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

Model Number 9207010/ 57065

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a customer reported to a medela customer service representative, that the housing for her advanced personal double breast pump adapter was cracked with no breach present.During the quality engineer's product evaluation of the advanced personal double breast pump adapter, it was determined later that the housing was breached which exposed the underlying electronic wiring.This has been determined to be a safety risk.

Manufacturer Narrative

The customer was sent a replacement transformer.Upon receipt of the damaged transformer, the evaluation performed by the quality engineering group on (b)(4) 2014, identified a breach in the transformer housing.Evaluation summary.A visual examination of the power supply revealed the transformer housing was breached, exposing inner electrical circuitry.A visual examination of the cord revealed no exposed wires.The returned power supply was taped together indicating that the breach occurred with the end user.Due to the unsafe state of the adapter, the power supply was not plugged in and therefore the voltage output across the dc plug could not be determined.The resistance across the dc plug measured open, which indicates that there is not a short in the dc cord.The resistance across the ac blades measured 54.8 ohms, and indicates that the thermal fuse did not blow.Any indication of smoke, fire or sparking could not be observed because the power supply was not plugged in during the product evaluation.The cause of the breach in the rev n transformer has not been determined at this time.It is currently being investigated under (b)(4).

• Brand Name: BP ADVANCED PERSONAL DOUBLE
• Manufacturer (Section D): MEDELA INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4381443
• MDR Text Key: 5240634
• Report Number: 1419937-2014-00938
• 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: Company Representative
• 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: 9207010/ 57065
• Device Catalogue Number: 9207010/ 57065
• Device Lot Number: REV N / 3113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/03/2014
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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