MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number 57081

Device Problems Crack (1135); Extrusion (2934)

Patient Problem No Information (3190)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a response email, requesting that she contact customer service for assistance.As of the date of this report, one attempt to contact to the customer to get additional information and to arrange for replacement of the power supply was unsuccessful.The issue with a damaged rev p power supply for the pump in style device is currently being evaluated under an investigation for (b)(4).A conclusion regarding this issue cannot be made at this time.

Event Description

On (b)(6) 2017, the customer alleged to medela llc via email that when she removed the power supply for her pump in style breast pump from the wall, the housing cracked and the electronics are hanging out.

Manufacturer Narrative

A replacement power supply was sent to the customer.When the product was received and evaluated, it was identified as a rev m and not a rev p, as previously reported.This issue with a damaged rev m power supply for the pump in style device was addressed in investigation ir12-0037.The investigation found that they were being damaged during shipment from the manufacturer to medela.This damage was causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the power supply to medela was not robust enough to handle all of the potential shipping, handling, and abuse conditions that could arise from logistics of the consolidation process.As a result of the investigation, the shipping and consolidation process was modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength was also increased to further protect the power supply during shipping.Since then, as a part of routine continuous improvement activities, a rev p power supply has been distributed to market, manufactured under a revised design and by a different manufacturer.

• Brand Name: BREASTPUMP PNSA STARTER
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 7167675
• MDR Text Key: 97668132
• Report Number: 1419937-2018-00005
• 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: 04/25/2018

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: 57081
• Device Catalogue Number: 57081
• Device Lot Number: REV M/LOT 5112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Distributor Facility Aware Date: 01/02/2018
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1