MAUDE report

MAUDE report 47172: AMBU MARK III RESUSCITATOR

Malfunction · received Oct 30, 1996 · AMBU INTERNATIONAL

Key facts

MDR report key 47172
Report number 9610691-1996-90001
Event type Malfunction
Brand name AMBU MARK III RESUSCITATOR
Model number AMBU MARK III
Catalog number 209035000
Manufacturer AMBU INTERNATIONAL
Product code BTM
Device class Class II
Date received by FDA Oct 30, 1996
Report date Oct 29, 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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