MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number 57062

Device Problems Crack (1135); Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

A replacement power supply was sent to the customer.The issue with a damaged rev n power supply for the pump in style device was addressed in investigation (b)(4), which was trended as part of the effectiveness check for (b)(4), which found that the power supplies were being damaged during shipment from the manufacturer to medela.As a part of routine continuous improvement activities, the rev n power supply was replaced with a rev p power supply, manufactured under a revised design and by a different manufacturer.

Event Description

On (b)(6) 2017, the customer alleged to medela (b)(4) that the pump in style breast pump won't power on with the power supply and that the housing was cracked open.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7168645
• MDR Text Key: 97476543
• Report Number: 1419937-2018-00008
• 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: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57062
• Device Catalogue Number: 57062
• Device Lot Number: 9207010 REV N 2213
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/29/2017
• Date Manufacturer Received: 12/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1