MAUDE report

MAUDE report 3798: DATASCOPE

Malfunction · received Jul 10, 1992 · DATASCOPE

Key facts

MDR report key 3798
Report number 3798
Event type Malfunction
Brand name DATASCOPE
Model number SYSTEM 90
Catalog number SYSTEM 90
Manufacturer DATASCOPE
Product code MFB
Date received by FDA Jul 10, 1992
Report date Jun 29, 1992
Report source Maude

At a glance

  • None Device problems coded
  • No 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:

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