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

Model Number 57081/9207010 REV N

Device Problems Component Falling (1105); Crack (1135)

Patient Problem No Information (3190)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement power supply.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 they are being damaged during shipment from the manufacturer to medela.This damage is 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 been increased to further protect the power supply during shipping.

Event Description

On (b)(6)2017, the customer alleged that the power supply for her pump in style breast pump fell and cracked into three pieces.The customer stated that she threw the power supply away.

• Brand Name: BREASTPUMP PNSA STARTER
• 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: 6724663
• MDR Text Key: 80648918
• Report Number: 1419937-2017-00194
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57081/9207010 REV N
• Device Catalogue Number: 57081/9207010 REV N
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/23/2017
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/19/2017
• 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