Catalog Number 50000000 |
Device Problems
Insufficient Heating (1287); Overfill (2404)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2023 |
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.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.
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Event Description
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It was reported that biomed stated that the arctic sun device would not heat.During functional testing the device did not heat past 17c.Biomed stated that they would use the service manual to check the resistance of the heating elements and replace the heater if they needed.
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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 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.H3 other text: the device was not returned.
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Event Description
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It was reported that biomed stated that the arctic sun device would not heat.During functional testing the device did not heat past 17c.Biomed stated that they would use the service manual to check the resistance of the heating elements and replace the heater if they needed.
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Search Alerts/Recalls
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