It was reported that during a test, the user plugged the ups end of the cpu to ups, and the usb cable into the + 12 volt side of the external ups power connection.After the large fire-ball, the ups shut off immediately.The usb connection on the cpu was welded to the cpu and cannot be removed yet the 'service' system still functions.The user was trying to simulate a clinical rep scenario to minimizing the possibility of this occurring in the field.No patient was involved and there was no injury to the user.
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H10 h3, h6: the device was intended for use in treatment and was returned for investigation.Investigation found that the service manager was simulating a possible mistake that could be made by a service rep.The cpu to ups usb cable connection on the ups is close to the battery extension terminals on the back of the ups.These terminals are exposed and being close to the usb connector, the service manager wanted to see what would happen if a service tech accidentally put the connector into one of the exposed terminal openings.When the connector was put into the + terminal (36vdc, 50 amps), what was described as a large fireball was produced and the usb cable was welded to the computer on the other end of the cable.A cover for the battery terminals that will snap into place based off of an off the shelf dust cover was designed to prevent future occurrences.The probable cause of the issue was design specification insufficient.The software version noted in the initial investigation documents was not identified in the dhr so we are unable to conduct a dhr review as a part of the investigation.A complaint history review found no other similar reports as this was the only complaint.A relationship between the device and the reported event could be established.
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