MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE; HGX

Model Number 57063/9207010

Device Problems Crack (1135); Scratched Material (3020)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

The customer reported to customer service that her pump in style transformer housing is cracked and the wires are exposed, indicating breach, which is a safety risk.

Manufacturer Narrative

A replacement transformer was sent to the customer.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 mfr medela.This damage is causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the mfr 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.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.Should additional info or the original product be received, resulting in new, changed, or corrected info, a f/u report will be filed at that time.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4801669
• MDR Text Key: 18387560
• Report Number: 1419937-2015-00159
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 05/20/2015

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: 57063/9207010
• Device Catalogue Number: 57063/9207010
• Device Lot Number: REV L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/18/2015
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 05/27/2015
• 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