The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for: noninvasive blood pressure (nibp); pulse rate (pr); noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2); body temperature in normal and axillary mode.The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for, noninvasive blood pressure (nibp), pulse rate (pr), noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), body temperature in normal and axillary mode.The device was returned to hillrom for repair.Upon inspection it was determined that the issue was with the power cord and there was no charring or signs of overheating observed internally with the device, the device was factory calibrated and the customer was sent a replacement power cord.The damaged power cord was forwarded on to the manufacturer for further investigation into the root cause of the malfunction.The customer did not provide the necessary information to determine the severity of the injury.Based on the limited details provided, there is no indication that the reported burn was a serious injury.Device inspection is pending.However, if the report of a spark were to recur, it would be likely to cause or contribute to a death or serious occur.If additional relevant information is received, the complaint will be reassessed, and the injury will be categorized accordingly.Any additional information received regarding this event will be submitted in a supplemental report.
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A sustainability investigation was completed on the returned power cord and no issues were found.The plug was disassembled, and no abnormality was observed in the welding between the terminal and wire.The returned sample passed hi-pot testing.Based on the inspection of the plug showing traces of fire on the live wire terminals, it is likely the socket was abnormal, or the plug was not properly inserted into the socket.Based on this information, no further actions are required.
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