MAUDE report

MAUDE report 40171: REDY 2000

Malfunction · received Sep 30, 1996 · GAMBRO HEALTHCARE

Key facts

MDR report key 40171
Report number 1647143-1996-00001
Event type Malfunction
Brand name REDY 2000
Catalog number 604487-006
Manufacturer GAMBRO HEALTHCARE
Product code FKP
Device class Class II
Date received by FDA Sep 30, 1996
Report date Sep 30, 1996
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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