MAUDE report

MAUDE report 4875: GEM-STAT INSTRUMENT WITH GEM-STAT PAK CARTRIDGE

Death · received Jul 21, 1992 · MILLINCKRODT SENSOR SYSTEMS, INC.

Key facts

MDR report key 4875
Report number 4875
Event type Death
Brand name GEM-STAT INSTRUMENT WITH GEM-STAT PAK CARTRIDGE
Model number 1280
Catalog number 4300(INSTRUMENT) 4301 (CART.)
Manufacturer MILLINCKRODT SENSOR SYSTEMS, INC.
Product code DRY
Device class Class II
Date received by FDA Jul 21, 1992
Report date Jul 20, 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
  • 1–9 Death reports for this brand
  • None 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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