Model Number 50000000E |
Device Problems
Use of Device Problem (1670); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that biomed stated they were testing the arctic sun device and it was not capping out at a particular temperature.The device kept getting hotter and hotter.
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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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Manufacturer Narrative
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Upon further review, bd has determined 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 biomed stated they were testing the arctic sun device and it was not capping out at a particular temperature.The device kept getting hotter and hotter.Per follow up information received on 05jan2022, the reported issue was user error and was not in use on a patient during event.The device was working fine and was in use.
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Search Alerts/Recalls
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