A replacement power supply was sent to the customer.The product was received and an evaluation confirmed that the power supply housing was breached.This issue with a damaged rev m power supply for the pump in style device was addressed in investigation (b)(4).The investigation found that they 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.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.
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