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

Model Number 57018W

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

A replacement pump was sent to the customer.The product involved in the complaint was returned and evaluated on (b)(6) 2017.The evaluation found that the power supply housing was breached, exposing the inner circuitry.The issue with a damaged rev p power supply for the pump in style device is currently being evaluated under an investigation for complaint category (b)(4).A conclusion regarding this issue cannot be made at this time.

Event Description

The customer alleged to medela llc that her pump in style motor was malfunctioning.

Manufacturer Narrative

The issue with a damaged pump in style rev p power supply for the pump in style device was evaluated under an investigation for complaint category (b)(4), which found that breaches in the rev p power supply housing are the result of an external large force impact and are not the result of a malfunction.

• Brand Name: ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 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: 7062666
• MDR Text Key: 93602548
• Report Number: 1419937-2017-00327
• 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,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• 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 P - 1644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/06/2017
• Date Manufacturer Received: 05/29/2018
• 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: N
• Patient Sequence Number: 1