MAUDE Adverse Event Report: MEDELA, LLC PUMP PERSONAL DOUBLE; PUMP, BREAST, POWERED

Model Number 57038/9207010

Device Problems Failure to Power Up (1476); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

A replacement power supply was sent to the customer.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).Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.Upon receipt and quality engineering evaluation, the product was received breached, which is a safety risk.

Event Description

On 12/08/2016, the customer reported to customer service that the transformer of her pump in style breast pump sparked while in the wall and was not connected to the pump. as a result, the  transformer will  not power the pump.

• Brand Name: PUMP PERSONAL DOUBLE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA, LLC; mchenry IL
• Manufacturer (Section G): MEDELA, LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6332619
• MDR Text Key: 67857554
• Report Number: 1419937-2017-00041
• 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: Other
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57038/9207010
• Device Catalogue Number: 57038/9207010
• Device Lot Number: REV N/1313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Distributor Facility Aware Date: 01/27/2017
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1