Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/21/2014 |
Event Type
malfunction
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Manufacturer Narrative
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No report of patient involvement.Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.
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Event Description
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During testing at ge manufacturing site, it was noted that the interlock system was not functional.There was no report of patient involvement.
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Manufacturer Narrative
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The unit was returned to the manufacturing site for investigation.Inspection of the unit revealed missing short interlock rod, spring and retaining screw.The mdr was filed following a retrospective review related to a (b)(4) response.
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Search Alerts/Recalls
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