MAUDE report

MAUDE report 43402: BREATHING CIRCUIT

Malfunction · received Oct 18, 1996 · DEROYAL TECHNOLOGIES

Key facts

MDR report key 43402
Report number MW1010096
Event type Malfunction
Brand name BREATHING CIRCUIT
Model number *
Catalog number 86-001294-00
Manufacturer DEROYAL TECHNOLOGIES
Product code BZO
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Oct 18, 1996
Report date Oct 7, 1996
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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