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

Model Number 9207010 (PRIOR TO REV L)_57036

Device Problems Break (1069); Sparking (2595); Protective Measures Problem (3015)

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

Event Date 06/25/2015

Event Type  malfunction  

Event Description

The customer reported to customer service that the transformer of her pump in style breast pump had sparked from exposed wires on the cord, which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.The customer reported sparking from the exposed wires on the transformer cord.She did not report of any fire or injury.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.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.Device not returned by the customer.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG
• 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: 4919002
• MDR Text Key: 6434321
• Report Number: 1419937-2015-00225
• 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: Patient
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010 (PRIOR TO REV L)_57036
• Device Catalogue Number: 9207010 (PRIOR TO REV L)_57036
• Device Lot Number: 15F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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