inforMED
DeathCAN

INGAGE

Received May 20, 2005 · Event occurred Apr 26, 2005

Report 1832475-2005-00001 · MDR key 604437

Device

Generic name

Oxygen Pressure Regulator (868.2700)

Manufacturer

Flotec, Inc.

Model number

DR803-710M1

Catalog number

*

Lot number

*

Product problems

  • Unknown (for use when the device problem is not known)

Patient

66 YR

  • Death

Narrative

Description of Event or Problem

PT WITH ACUTE HEMORRAGIC PANCREATITIS, POLYNEUROPATHY, POST TRACHEOSTEMY, AND RESPIRATORY FAILURE REQUIRING MECHANICAL VENTILATION DIED DURING MRI WHILE BEING SUPPLIED OXYGEN WITH A HAND BAGGING PROCEDURE AT 15 LITERS PER MINUTES FOR 45 MINS.

Description of Event or Problem

NI