MAUDE report

MAUDE report 3998: DATASCOPE

Malfunction · received Jul 6, 1992 · DATASCOPE

Key facts

MDR report key 3998
Report number 3998
Event type Malfunction
Brand name DATASCOPE
Model number 692
Catalog number 692
Manufacturer DATASCOPE
Product code DRK
Device class Class III
Date received by FDA Jul 6, 1992
Report date Jun 29, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 10–99 Death reports for this brand
  • 100–999 Injury reports for this brand
  • 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:

Browse all MAUDE medical device reports