Generator, Pulsatile Flow, Cardiopulmonary Bypass

What the Data Shows About Generator, Pulsatile Flow, Cardiopulmonary Bypass

The FDA MAUDE database aggregates 428 adverse-event reports for Generator, Pulsatile Flow, Cardiopulmonary Bypass spanning the period from 2007 through 2011. Of these, 0 are classified as death reports, 0 as injury reports, and 428 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 1 distinct event type and 2 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. Reports are associated with 4 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 5 years of MAUDE data, with the peak single-year volume reaching 236 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 1 reported care-setting category (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.