MAUDE report

MAUDE report 17885: PULSE OXIMETER

Injury · received Nov 21, 1994 · NONIN MEDICAL, INC.

Key facts

MDR report key 17885
Report number MW1004093
Event type Injury
Brand name PULSE OXIMETER
Model number 8604
Manufacturer NONIN MEDICAL, INC.
Product code DQA
Device class Class II
Date received by FDA Nov 21, 1994
Report date Nov 4, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 Injury reports for this brand
  • Yes 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