Catalog Number 5000-01-02 |
Device Problem
Fracture (1260)
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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 06/29/2022 |
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 had stopped working.Technician reported that the screen was cracked and had stopped working, resulting in it being taken out of service.
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Manufacturer Narrative
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Based on the follow-up information, bd has determined 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 had stopped working.Technician reported that the screen was cracked and had stopped working, resulting in it being taken out of service.Per follow up information received on 09aug2022, there was no patient involved.Due to the cracked screen and deep scratches, the device was unresponsive to touch and could not be operated.Control panel replaced due to reported issue.
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Search Alerts/Recalls
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