MAUDE report

MAUDE report 3134: OXIMETRIC SWAN GANZ CATHETER

Malfunction · received Jul 31, 1992 · ABBOTT CRITICAL CARE SYSTEMS

Key facts

MDR report key 3134
Report number 3134
Event type Malfunction
Brand name OXIMETRIC SWAN GANZ CATHETER
Model number UNKNOWN
Catalog number UNKNOWN
Manufacturer ABBOTT CRITICAL CARE SYSTEMS
Product code DQE
Device class Class II
Date received by FDA Jul 31, 1992
Report date Jul 28, 1992
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
  • None Death reports for this brand
  • None 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:

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