MAUDE report

MAUDE report 77358: ARROW/KONTRON KAAT II PLUS IABP

Death · received Mar 19, 1997 · ARROW INTERNATIONAL, INC.

Key facts

MDR report key 77358
Report number 1219856-1997-00048
Event type Death
Brand name ARROW/KONTRON KAAT II PLUS IABP
Catalog number IAP-0025
Manufacturer ARROW INTERNATIONAL, INC.
Product code DSP
Device class Class II
Date received by FDA Mar 19, 1997
Report date Mar 18, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No 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:

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