MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
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Catalog Number 735-02 |
Device Problems
Failure to Sense (1559); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
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 arctic sun device did not detect the temperature probe.Per review of wo on (b)(6) 2024, device was used on patient and no patient injury was detected.Per follow up information received via email on (b)(6) 2024, the device would be repaired onsite by changing the nelcor 73502 cable.The issue was not resolved yet.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue is a failed temperature in cable.The device was evaluated upon receipt.The device was working but the temperature cable in nellcor was the problem because it was broken.The temperature cable in nellcor was not working correctly.Replaced temperature cable.A dhr review is not required as the serial number is unknown.The reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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 actual/suspected device was inspected.
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Event Description
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It was reported that the arctic sun device did not detect the temperature probe.Per review of wo on 23feb2024, device was used on patient and no patient injury was detected.Per follow up information received via email on 23feb2024, the device would be repaired onsite by changing the nelcor 73502 cable.The issue was not resolved yet.Per sample evaluation results on 06mar2024, it was reported that the fill tube was not working correctly.
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Search Alerts/Recalls
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