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Catalog Number C-OM-10000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer customer gradually increased the vacuum pressure to 30kpa, and then to 40kpa, but it was unable to secure the device.Opened another om-10000, replaced the tube, and increased the pressure.Then it was able to secure the device.The ggj sales person checked the device connection and no problems were found.The tube seems to have a problem.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer customer gradually increased the vacuum pressure to 30kpa, and then to 40kpa, but it was unable to secure the device.Opened another om-10000, replaced the tube, and increased the pressure.Then it was able to secure the device.The ggj sales person checked the device connection and no problems were found.The tube seems to have a problem.The hospital did not report any patient effects.
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Search Alerts/Recalls
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