Customer initially reports no patient injury.Power supply plugged in and caught fire.On (b)(6) 2015 customer reports "no surgery planned.We just received new power supply (407481) for the battery bay (90523) and manager plugged the power supply into its bay.Plugged into wall and fire caught inside the battery bay.Fire started a second after i plugged it in." no harm done, no patient involvement.Event took place in clinic department, not in the operation room.2 of 2 related complaint.
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9/9/15 integra investigation completed.Method: failure analysis, device history evaluation failure analysis - the single bay charger was returned, not 60w power supply.Single bay charger power on without a fire or smoke of any kind.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order / manufacturing change order history: none related.Corrective action preventive action history: none related.Health hazard evaluation history: none.Conclusion: it appears the most likely scenario is that the charge controller ic, u4 failed internally, turning q3 on, connecting 24v to q4a drain.Q4a turned on linearly, overheating, which caused a gate to drain short, shorting the 24vdc to ground thru u4-3.Our chargers have been tested to and passed ce level iv esd, 15,000v, on all connectors so eos/esd was not the cause of the failure.
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