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Model Number 50000000 |
Device Problem
No Display/Image (1183)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2022 |
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.
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Event Description
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It was reported that the arctic sun device was on, but the screen was blank.Mis advised that they need to swap out to a different device and send to biomed for repair.As per follow-up information, received via email on 15dec2022, biomed told nurse that it repeated booted to an alarm 47 (control panel communication).They discussed that they would need to investigate further to isolate the problem to the control panel, wiring, or the processor card.Biomed stated that they would replace the part once they determined the root cause.
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Manufacturer Narrative
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Upon further review, bd has determined that this event is not reportable.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 device was not returned.
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Event Description
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It was reported that the arctic sun device was on, but the screen was blank.Mis advised that they need to swap out to a different device and send to biomed for repair.As per follow up information received via email on 15dec2022, biomed told nurse that it repeated booted to an alarm 47 (control panel communication).They discussed that they would need to investigate further to isolate the problem to the control panel, wiring, or the processor card.Biomed stated that they would replace the part once they determined the root cause.Per follow up information received via phone on 29dec2022, biomed stating that they had replaced the control panel, but they tried to fill the device and device was leaking out of the front per email response received from technician support and biomed communication on 30dec2022, biomed did not add the cleaning solution when refilling, so they overfilled the tank.Per review of wo on 01jan2023, there was no patient involvement.
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Search Alerts/Recalls
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