inforMED
MalfunctionCAN

OXYTOTE

Received Jun 12, 2024 · Event occurred Apr 17, 2024

Report 19518558 · MDR key 19518558

Device

Generic name

Regulator, Pressure, Gas Cylinder

Model number

MNDR-600

Patient

NA · Unknown

  • Low Oxygen Saturation
  • Low Oxygen Saturation

Narrative

Description of Event or Problem

CHARGE RN SETTLED PT IN ROOM WITH TRANSPORT. PT ON 4L NASAL CANNULA AND FOUND TRANSPORTABLE O2 TANK WAS NOT TURNED ON OR DELIVERING OXYGEN. PT SUSTAINED O2 SAT OF 86-88% WITHOUT O2 - DENIES ANY SOB OR DISCOMFORT. PRIMARY RN THEN CONNECTED PT TO WALL O2. O2 SAT IMPROVED TO 95%. NO OTHER CONCERNED AT THIS TIME. APSM NOTIFIED ON UNIT IN PERSON. THIS IS A USER ERROR BUT AN INHERENT RISK TO THIS TWO-STEP TURNING ON DESIGN WHICH HAS LED TO A LOT OF EVENTS WHERE OXYGEN IS NOT TURNED ON BUT THE GAUGE IS NOT DESIGNED TO ALERT FOR THAT. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER).