MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE (UNKNOWN); PUMP, BREAST, POWERED

Model Number PUMP IN STYLE (UNKNOWN)

Device Problems Burst Container or Vessel (1074); Loss of Power (1475); Sparking (2595)

Patient Problem No Information (3190)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The customer was contacted by a complaint handler to get additional information, with no response as of the date of this report.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

On (b)(6) 2018, the customer alleged to medela llc via email that the power supply for her pump in style breast pump "literally exploded." she alleged that there was a pop and "like a spark," the plastic broke, and the power supply stopped working.She indicated that she used her battery pack to pump, so she knows the pump was not affected.

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: PUMP IN STYLE (UNKNOWN)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 7340753
• MDR Text Key: 102598291
• Report Number: 1419937-2018-00082
• 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
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PUMP IN STYLE (UNKNOWN)
• Device Catalogue Number: PUMP IN STYLE (UNKNOWN)
• Device Lot Number: 9207010/REV P
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/05/2018
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1