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

Model Number 9207010-57XXX

Device Problems Material Separation (1562); Sparking (2595)

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

Event Date 11/25/2014

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).The product involved in the complaint was not returned for eval/investigation at this time.Therefore, no conclusion can be made as to the cause of the event.

Event Description

The customer called in to customer svc to report that her transformer for her pump in style pump had fallen apart and she saw sparking.

• Brand Name: PUMP IN STYLE (ITEM # UNK)
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4355704
• MDR Text Key: 19373065
• Report Number: 1419937-2014-00923
• 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: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010-57XXX
• Device Catalogue Number: 9207010-57XXX
• Device Lot Number: REV N-3113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2014
• 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: Unknown
• Patient Sequence Number: 1