As a result off the monthly maude search, hillrom became aware of a medwatch report of a flash of light and smoke event regarding an eli380 electrocardiograph.Information on the complainant and the device, including contact details, location and serial number, were not provided in the report received.This report was filed in our complaint handling system as (b)(4).
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As a result off the monthly maude search, hillrom became aware of a medwatch report of a flash of light and smoke event regarding an eli380 electrocardiograph.The eli380 device is indicated for use to acquire, analyze, display, and print electrocardiograms.Device is indicated for use to provide interpretation of the data for consideration by a physician.Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.It is not intended as a sole means of diagnosis.The interpretations of ecg offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.Device is indicated for use on adult and pediatric populations.The device is not intended to be used as a vital signs physiological monitor.All welch allyn electrical devices are designed and tested to meet all applicable safety and flammability regulations.Welch allyn's vital signs, cardio and monitoring electrical devices are not held by the user and therefore decrease the likelihood that the user would sustain a 1st or 2nd degree burn if the device were to become hot.If these burns were to occur, they would generally not be considered serious and would heal without further medical intervention.Information regarding the safety and warnings specific to each device is in the instruction for use (ifu).Additionally, if a device were to get hot to touch, spark, have burn marks or burned components a trained clinician would not use the device and remove it from the patient's environment.Specific information on the complainant and the device, including contact details, location and serial number, were not provided in the report received.Therefore, a thorough investigation of the event and the device could not be performed.Although there was no patient injury associated with the reported event, if a similar event were to recur, it could contribute to a serious injury or death.Therefore, hillrom considers this complaint a reportable event, if additional information on the complainant and/or the device will be received, the event will be re-assessed and categorised accordingly.Location of the device unknown.
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