MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK; HGX

Model Number 9207010/57062

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Crack (1135); Component Missing (2306); Device Unsafe to Use in Environment (2918)

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

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

A replacement power supply was sent to the customer.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusion can be made as to the cause of the event.Should additional information or the original product be received, resulting in new, changed, or correct information, a follow up report will be filed at that time.This issue with the damaged transformer housing for the pump in style device was addressed in investigation (b)(4).The investigation found that the transformers 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 transformers to medela is 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 has been modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength has also been increased to further protect the transformers during shipping.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.

Event Description

The customer reported to customer service that the transformer for her pump in style breast pump had fallen off the table and cracked.The outer housing of the transformer is now missing a piece, exposing the inner electronics, which is a safety risk.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 5072008
• MDR Text Key: 26048308
• Report Number: 1419937-2015-00263
• 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: Patient
• Report Date: 09/10/2015

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: 9207010/57062
• Device Catalogue Number: 9207010/57062
• Device Lot Number: REV M - UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1