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Model Number N/A |
Device Problem
Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that there was a suction issue.The event timing was outside of surgery.There is no harm or delay reported.No adverse events were reported as a result of this malfunction due diligence is complete and no additional information is available.Upon investigation, there was a char in the fuse.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified the following related repair: there was char in the fuse.A fuse was blown and was replaced which resolved the reported issue.Root cause - the vacuum pump is required to create suction in order for the unit to function as intended.Mechanical failure can occur within the vacuum pump assembly with either the pump failing to generate negative pressure, or with a failure of the carbon filter.Over time and with continuous use, the internal integrity of the vacuum pump can degrade and no longer be able to create the pressure needed for desired suction levels.Likewise, the carbon filter can back out of the assembly or over tighten, again causing suction failure.A mechanical failure of the component will cause an overall suction failure in the unit and will prompt vacuum sensor errors.Electrical failure can occur when the unit draws an excess of electrical current; this will cause the fuse for the vacuum pump to trip, denying the pump power and causing the component to fail and prompt vacuum sensor errors.The event was confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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