A replacement power adapter was sent to the customer and requested the defective power adapter be returned for evaluation.The defective power adapter has not been received at medela as of 2/1/16.The product involved in the complaint was not returned for evaluation/investigation.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 corrected information, a follow up report will be filed at that time.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.
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On (b)(6) 2016, the customer contacted medela customer service stating that her pump in style transformer housing cracked, exposing inner electrical circuitry, which is a safety risk.
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