MAUDE report

MAUDE report 3521: COMPONENT MONITORING SYSTEM

Death · received Dec 22, 1992 · HEWLETT PACKARD

Key facts

MDR report key 3521
Report number 3521
Event type Death
Brand name COMPONENT MONITORING SYSTEM
Model number M104619
Catalog number M1176A
Manufacturer HEWLETT PACKARD
Product code KMI
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Dec 22, 1992
Report date Dec 17, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 10–99 Death reports for this brand
  • 10–99 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:

Browse all MAUDE medical device reports