MAUDE report

MAUDE report 20169: STAR LUMEN 5 CHANNEL LOW PRESSURE MEDICAL GAS TUBING

Malfunction · received Mar 8, 1995 · HUDSON RESPIRATORY CARE, INC.

Key facts

MDR report key 20169
Report number MW1005359
Event type Malfunction
Brand name STAR LUMEN 5 CHANNEL LOW PRESSURE MEDICAL GAS TUBING
Catalog number 1112
Manufacturer HUDSON RESPIRATORY CARE, INC.
Product code BYX
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Mar 8, 1995
Report date Feb 24, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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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