Catalog Number UNKNOWN-2008K@HOME MACHINE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 04/01/2018 |
Event Type
Death
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Event Description
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This is a report of a hemodialysis patient who expired.A patient letter envelope regarding a software upgrade letter was received indicating that the patient passed away.No further information is available at this time.Should additional information become available, the file will be reassessed and updated accordingly.
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Manufacturer Narrative
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Plant investigation: the actual device was not returned to the manufacturer for physical evaluation.Furthermore, an investigation of the device manufacturing records was not able to be conducted by the manufacturer as the product serial number of the device was unknown, therefore an investigation of the device manufacturing records was unable to be conducted by the manufacturer.However; a device is not released if it does not meet requirements or is nonconforming.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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