Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/24/2015 |
Event Type
malfunction
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Manufacturer Narrative
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No report of pt involvement.Ge healthcare's investigation into the reported occurrence is still ongoing.A f/u report will be issued when the investigation has been completed.
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Event Description
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During testing of the unit, it was noted that the interlock system was not functional.There was no report of pt 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 the unit failed the interlock rod testing.The mdr was filed following a retrospective review related to a 483 response.
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Search Alerts/Recalls
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