Catalog Number 5000-01-01 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2021 |
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 received an error 64 (non recoverable system error) and they need to restart the device to finish therapy.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was initially reported in error as per additional information received this event is not reportable.H11: section a through f - the information provided by bd 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 bd.
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Event Description
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It was reported that the arctic sun device received an error 64 (non recoverable system error) and they need to restart the device to finish the therapy.Per follow up with ibc on 04jun2021 it was stated that the patient completed the therapy with the same arctic sun device.They had to shut down the device before restarting the therapy.
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Search Alerts/Recalls
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