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

Model Number PUMP IN STYLE (UNKNOWN)

Device Problems Crack (1135); Failure to Power Up (1476)

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

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement pump and the damaged power supply was requested for return.The damaged power supply was received and evaluated.The power supply was found to have a breach housing which exposed inner circuitry.This issue with a damaged rev m power supply for the pump in style device was addressed in investigation (b)(4).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.

Event Description

On (b)(6)2017, the customer alleged that her pump in style breast pump was not powering on.She tried two different power supplies and different outlets.She indicated that the power supply housing for one of the power supplies, which was from her old pump, was damaged with a crack near the prongs.

• Brand Name: PUMP IN STYLE (UNKNOWN)
• 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: 6794949
• MDR Text Key: 83249288
• Report Number: 1419937-2017-00222
• 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: 08/15/2017

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: No Information
• Device Model Number: PUMP IN STYLE (UNKNOWN)
• Device Catalogue Number: PUMP IN STYLE (UNKNOWN)
• Device Lot Number: 9207010 REV M 4912
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/28/2017
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1