Model Number BI-700-00027-120 |
Device Problems
Mechanical Problem (1384); Intermittent Loss of Power (4016)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.A medtronic representative went to the site to test the equipment.Testing revealed that the relay and varistor were causing the motor to stop prematurely.Replaced the relay and varistor and the system regained functionality.Systems checkout was performed and system was functioning as intended.
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Event Description
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Medtronic received information regarding an imaging device being used for a sacroiliac and thoracolumbar procedure.It was reported that the system was not taking a full 3d spin and would stop after about a quarter or half spin was captured.The system was also not raising all the way up.There was no patient impact reported.
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Manufacturer Narrative
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Additional information: it was determined there was an unconfirmed accidental radiation occurrence due to early termination of acquisition.No defect in an electronic product or failure to comply per 21 cfr 1003 was discovered.The investigation concluded that the issue was due to hardware.Relay and varistor components replaced to resolve.Number of people exposed: 1 - patient total number of people in or unknown.Estimated absorbed or effective dose information is not available.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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