The customer was provided with information for purchasing a new power supply and the original power supply was requested for evaluation; however, the customer disposed of the power supply.This issue with a damaged rev n power supply for the pump in style device was addressed in investigation (b)(4) which was trended as part of the effectiveness check for (b)(4), which found that the power supplies 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 been increased to further protect the power supply during shipping.
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