MAUDE report

MAUDE report 16047: MONITORING SYSTEM

Malfunction · received Sep 13, 1994 · PURITAN-BENNETT CORP.

Key facts

MDR report key 16047
Report number MW1003321
Event type Malfunction
Brand name MONITORING SYSTEM
Model number 240
Manufacturer PURITAN-BENNETT CORP.
Product code DRT
Device class Class II
Date received by FDA Sep 13, 1994
Report date Sep 12, 1994
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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