MAUDE Adverse Event Report: MEDELA LLC ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK); PUMP, BREAST, POWERED

Model Number 57018W

Device Problems Break (1069); Crack (1135)

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

Event Date 04/18/2018

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) 2018, the customer alleged to medela llc that the housing on the power supply for her pump in style breast pump cracked and the metal prongs are broken.

• Brand Name: ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)
• 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: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7472097
• MDR Text Key: 106979949
• Report Number: 1419937-2018-00114
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57018W
• Device Catalogue Number: 57018W
• Device Lot Number: 9207010 REV N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2018
• 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