Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2013 |
Event Type
malfunction
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Manufacturer Narrative
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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 the manufacturing site, it was noted that the interlock system was not functional.
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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 interlock rods came apart and were reassembled wrong.The mdr was filed following a retrospective review related to a 483 response.
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Search Alerts/Recalls
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