MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number 9207010_57063

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

A replacement power adapter was sent to the customer and requested the defective power adapter be returned for evaluation.A product evaluation on 2/1/16 revealed the transformer housing was cracked open, exposing inner electrical circuitry, which is a safety risk.This issue with a 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

On (b)(6) 2016, the customer reported to medela customer service that her pump in style transformer housing cracked open, exposing inner electrical circuitry, which is a safety risk.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate dr; mchenry, IL 60050 ; 8155782220
• MDR Report Key: 5414187
• MDR Text Key: 38131730
• Report Number: 1419937-2016-00024
• 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
• Type of Report: Initial
• Report Date: 01/11/2016

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_57063
• Device Catalogue Number: 9207010_57063
• Device Lot Number: REV M / LOT UNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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