MAUDE report

MAUDE report 72458: ADULT MANUAL RESUSCITATOR BAG

Injury · received Feb 25, 1997 · ENGINEERING MEDICAL SYSTEMS

Key facts

MDR report key 72458
Report number 6000008-1997-00008
Event type Injury
Brand name ADULT MANUAL RESUSCITATOR BAG
Model number 2K8017
Catalog number 2K8017
Manufacturer ENGINEERING MEDICAL SYSTEMS
Product code BTM
Device class Class II
Date received by FDA Feb 25, 1997
Report date Feb 25, 1997
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
  • 1–9 Death reports for this brand
  • 1–9 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