Catalog Number 0450000000I |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Code Available (3191)
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Event Date 08/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the pump stopped working causing the procedure be converted into open surgery.The procedure was completed successfully.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: "error" in display.Confirmed failure: needs calibration, software upgrade needed, error message displayed probable root cause: software; bad touch screen calibration ; use error.The reported failure mode will be monitored for future reoccurrence (b)(4).
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Event Description
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It was reported that the pump stopped working causing the procedure be converted into open surgery.The procedure was completed successfully.
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Search Alerts/Recalls
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