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Model Number 60000000 |
Device Problems
Defective Component (2292); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the nurse stated the touch screen was frozen and could not start therapy.Nurse has turned it off and on several times.Mis had the nurse power off, unplug, wait 30 seconds, plug in, power on.Device would not let nurse push any buttons.Nurse would send to biomed and look for another arctic sun device.As per additional information received via phone on (b)(6) 2022, the device was sent to biomed.Biomed was still having a frozen screen.Nurse tried doing a hard reboot, but screen still will not work.No patient injuries reported.Biomed would like to send the device in for repair.As per tech support communication with biomed on (b)(6) 2022, biomed was uninterested in replacing the control panel onsite and was sending the device in for repair and requested a loaner.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue is due to a failed control panel.During evaluation, it was confirmed that the unit control panel was frozen.Used u.I.To complete decontamination.Control panel was replaced.The arctic sun stat passed all performance testing, and electrical safety tests and is functioning properly and ready for use.The device did not meet specifications, and was influenced by the reported failure.The device was in use on a patient.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text: the actual/suspected device was evaluated.
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Event Description
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It was reported that the nurse stated the touch screen was frozen and could not start therapy.Nurse has turned it off and on several times.Mis had the nurse power off, unplug, wait 30 seconds, plug in, power on.Device would not let nurse push any buttons.Nurse would send to biomed and look for another arctic sun device.As per additional information received via phone on 14nov2022, the device was sent to biomed.Biomed was still having a frozen screen.Nurse tried doing a hard reboot, but screen still will not work.No patient injuries reported.Biomed would like to send the device in for repair.As per tech support communication with biomed on 21nov2022, biomed was uninterested in replacing the control panel onsite and was sending the device in for repair and requested a loaner.
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Search Alerts/Recalls
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