Model Number ELI380-ACX11 |
Device Problem
Wireless Communication Problem (3283)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The eli 380 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.If the (b)(4) device loses connection to the wireless network, the device is unable to transmit or receive ekg¿s.This failed connection may result in a delay of patient treatment which may cause or contribute to a serious injury or death.Therefore, hillrom is reporting this alleged connection failure as a product malfunction.No further information is available on the repair of the device at this time.The investigation is ongoing and the investigation and resolution details will be submitted in a supplemental report.
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Event Description
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Hillrom received a report from the account stating that the eli 380 device would drop connection to the wireless network.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
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Event Description
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Hillrom received a report from the account stating that the eli 380 device would drop connection to the wireless network.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
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Manufacturer Narrative
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The device was returned for evaluation.The eli380 device was upgraded to a new software version to correct the reported issue.Following this, the device was working as designed.Based on this information, no further action is required at this time.
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Search Alerts/Recalls
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