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Model Number 60000000 |
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 03/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that the biomed received a note about a arctic sun device from the nurses.Per the note, the nurses were using a device on a patient.The device was in cooling and automatically swapped over to rewarming after 74 hours in cooling.The note stated the device was supposed to remain in cooling for 96 hours before switching to rewarming.Biomed did not have the device in the depot, it was still on the floor.Mis informed biomed could download the data from the event to see why the therapy swapped from cooling to rewarming and verify the device settings.Mis informed biomed to get the device if able and call us back so they could walk through downloading the data.Mis recommended to inform nurses if they have any issues with therapy in the future, to call for clinical support as we were available.
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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.The device was not returned.
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Event Description
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It was reported that the biomed received a note about a arctic sun device from the nurses.Per the note, the nurses were using a device on a patient.The device was in cooling and automatically swapped over to rewarming after 74 hours in cooling.The note stated the device was supposed to remain in cooling for 96 hours before switching to rewarming.Biomed did not have the device in the depot, it was still on the floor.Mis informed biomed could download the data from the event to see why the therapy swapped from cooling to rewarming and verify the device settings.Mis informed biomed to get the device if able and call us back so they could walk through downloading the data.Mis recommended to inform nurses if they have any issues with therapy in the future, to call for clinical support as we were available.
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Manufacturer Narrative
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Per investigator evaluation, bd has determined that this mdr event is not reportable.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.
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Search Alerts/Recalls
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