Model Number 9733560XOM |
Device Problems
Mechanical Problem (1384); Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9733320r pend, serial/lot #: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the system displayed an axiem box communication error.The rep checked the number being displayed on the axiem box and it was an 8.The axiem box was to be replace.There was no patient present when this issue was identified.
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Manufacturer Narrative
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Other relevant device(s) are: product id: 9733405, serial/lot #: unknown.A medtronic representative went to the site to troubleshoot.It was noted that wiggling the pc communication cable on the axiem box caused the axiem code to go between 8 <(>&<)> 7.The system 9733320 axiem integrated 4 port (lot# 0200065248) was returned for analysis.Analysis found that all ports were tracking normal.The unit was left connected to a test system in excess of twenty four hours and no issues were observed, as tracking remained consistent throughout the duration of testing.No failure was found.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The manufacture representative documented the system checkout.The cable replacement was documented.The issue resolved.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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