MAUDE report

MAUDE report 24526: HEART LUNG BYPASS UNIT

Death · received Jul 20, 1995 · MEDTRONICS BIO-MEDICS, INC.

Key facts

MDR report key 24526
Report number 24526
Event type Death
Brand name HEART LUNG BYPASS UNIT
Model number 540
Manufacturer MEDTRONICS BIO-MEDICS, INC.
Product code DWA
Device class Class II
Date received by FDA Jul 20, 1995
Report date Jan 24, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • None Injury reports for this brand
  • Yes Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports