MAUDE report

MAUDE report 43027: COMPANION 550

Malfunction · received Oct 11, 1996 · CRYOGENIC EQUIPMENT DIV., PURITAN-BENNETT

Key facts

MDR report key 43027
Report number 1825511-1996-00016
Event type Malfunction
Brand name COMPANION 550
Model number C550
Catalog number B-778051-00
Manufacturer CRYOGENIC EQUIPMENT DIV., PURITAN-BENNETT
Product code BYJ
Device class Class II
Date received by FDA Oct 11, 1996
Report date Oct 11, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 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:

Browse all MAUDE medical device reports