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Model Number 57063 |
Device Problems
Break (1069); Sparking (2595)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The customer was sent a replacement power supply.On 01/25/2018, the customer reported via email that she had disposed of the damaged power supply.This issue with a damaged rev l power supply for the pump in style device was addressed in investigation (b)(4).The investigation found that they were being damaged during shipment from the manufacturer to medela.This damage was 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 increased to further protect the power supply during shipping.Since then, as a part of routine continuous improvement activities, a rev p power supply has been distributed to market, manufactured under a revised design and by a different manufacturer.
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Event Description
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On (b)(6) 2018, the customer alleged to medela llc that she purchased her pump in style breast pump sometime before her first child was born, in 2011.She was using it again with her third child, and when unplugging the power supply, the cover broke off, there was a pop and sparks sprayed around.
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Search Alerts/Recalls
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