MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number 57062/9207010

Device Problem Crack (1135)

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

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

A replacement power supply was sent to the customer.In follow up with the customer on 07/13/2017 by complaint handling, the customer indicated that she had nothing else to report about the power supply, the replacement power supply was working fine and she returned the damaged power supply.As of the date of this report, the damaged power supply has not been received.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 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 increased to further protect the power supply during shipping.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.

Event Description

On (b)(6) 2017, the customer alleged that her pump in style power supply housing cracked on the side where the prongs are located and she can see the insides of the housing.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• 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 60051
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6728203
• MDR Text Key: 80685161
• Report Number: 1419937-2017-00199
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57062/9207010
• Device Catalogue Number: 57062/9207010
• Device Lot Number: REV M/5112
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/29/2017
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/20/2017
• 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
• Patient Outcome(s): Other