MAUDE Adverse Event Report: MEDELA INC PUMP IN STYLE; PUMP, BREAST, POWERED

Model Number 9207010/57XXX

Device Problems Break (1069); Split (2537); Sparking (2595)

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

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement transformer.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.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.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

On (b)(6) 2016, the customer reported to customer service that the power cord on the transformer for her pump in style breast pump had split and wires were exposed.She said she witnessed sparking, which is a safety risk on a prior to rev l pump in style transformer.

• Brand Name: PUMP IN STYLE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA INC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA, INC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL ; 8155782220
• MDR Report Key: 5388946
• MDR Text Key: 36935619
• Report Number: 1419937-2016-00011
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• 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: PRIOR TO REV L- 13B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2016
• 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