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Catalog Number 50000000E |
Device Problem
Alarm Not Visible (1022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
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 the nurse stated that they have a patient in normothermia.The arctic sun device has been giving an audible beep but there was no alarm message.Recommended nurse to pause therapy, empty the pads, and then turn the device off and back on.Nurse would try this and call back if still having issues.
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Manufacturer Narrative
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Per additional information received, 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.
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Event Description
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It was reported that the nurse stated that they have a patient in normothermia.The arctic sun device has been giving an audible beep but there was no alarm message.Recommended nurse to pause therapy, empty the pads, and then turn the device off and back on.Nurse would try this and call back if still having issues.Per follow up information received via phone on 09apr2024, it was reported that therapy was completed on the male patient without any impact.No other identifying info could be provided.Mis instructed the nurse to turn the device off and then back on.Once the device was restarted, the issue was resolved.The device will not be sent in for evaluation.
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Search Alerts/Recalls
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