MAUDE Adverse Event Report: MEDELA, INC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number 9207010/57063

Device Problems Crack (1135); Protective Measures Problem (3015)

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

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement power supply.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 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.

Event Description

On (b)(6) 2017, the customer reported to customer service that the transformer housing of her pump in style breast pump had cracked and opened exposing the inner electronics, which is a safety risk.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA, INC; 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: 6523053
• MDR Text Key: 73911046
• Report Number: 1419937-2017-00123
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010/57063
• Device Catalogue Number: 9207010/57063
• Device Lot Number: REV N / 2413
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/17/2017
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 04/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1