MalfunctionCAN

OXYTOTE

Received May 2, 2024 · Event occurred Apr 27, 2024

Report 19228554 · MDR key 19228554

Device

Generic name

Regulator, Pressure, Gas Cylinder

Manufacturer

Western/scott Fetzer Company

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

EVENTS ON SAME DAY. EVENT #1: O2 TANK DISPLAYING ERROR MESSAGE. ERROR MESSAGE ON TANK THAT APPEARED FULL. GAUGE ON TANK IS DEFECTIVE. REMOVE TANK FROM SERVICE. EVENT #2: O2 TANK DISPLAYING ERROR MESSAGE (2ND TANK TODAY, SAME UNIT CCU). ERROR MESSAGE ON TANK THAT APPEARED FULL. GAUGE ON TANK IS DEFECTIVE. REMOVED TANK FROM SERVICE. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER) RETURNED TO MANUFACTURER VIA OUR DISTRIBUTOR (B)(4).