MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE BREAST PUMP; HGX

Model Number 9207010/57XXX

Device Problems Fire (1245); Smoking (1585); Sparking (2595)

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

Event Date 06/22/2015

Event Type  malfunction  

Manufacturer Narrative

A replacement power supply was sent to the customer.The customer reported that she witnessed smoking, flame and sparks from the transformer.She did not report of any injury.The product was returned and evaluated by quality engineering on (b)(4) 2015.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.

Event Description

The customer's father reported to customer service that the transformer housing of his daughter's pump in style breast pump had started to smoke, spark and flame.

• Brand Name: PUMP IN STYLE BREAST PUMP
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 4921867
• MDR Text Key: 22460502
• Report Number: 1419937-2015-00224
• Device Sequence Number: 0
• Product Code: HGX
• 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: Patient
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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: PRIOR TO REV L/16I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1