MAUDE report

MAUDE report 7629

Malfunction · received Feb 7, 1994 · SPACELABS

Key facts

MDR report key 7629
Report number 7629
Event type Malfunction
Model number SP02 MODULE
Manufacturer SPACELABS
Date received by FDA Feb 7, 1994
Report date Aug 5, 1993
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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