Catalog Number 60000000 |
Device Problems
Insufficient Heating (1287); Use of Device Problem (1670)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/08/2023 |
Event Type
malfunction
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Event Description
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It was reported that biomed had arctic sun device that had been alerted 113 (reduced water temperature control) and will not get above 19c.
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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.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.
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Manufacturer Narrative
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Per investigator evaluation, bd has determined that this mdr event is not reportable.H11: section a through f - the information provided by bd represents all 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.H3 other text: the device was not returned.
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Event Description
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It was reported that biomed had arctic sun device that had been alerted 113 (reduced water temperature control) and will not get above 19c.
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Search Alerts/Recalls
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