MAUDE report

MAUDE report 17771

Malfunction · received Jul 29, 1994 · GENERAL ELECTRIC MEDICAL SYSTEM

Key facts

MDR report key 17771
Report number 17771
Event type Malfunction
Model number 45561630
Catalog number LOE PEDAL - 45067456
Manufacturer GENERAL ELECTRIC MEDICAL SYSTEM
Date received by FDA Jul 29, 1994
Report date Jun 6, 1994
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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