inforMED
MalfunctionCAN

OXYTOTE

Received Nov 21, 2024 · Event occurred Oct 21, 2024

Report 20745109 · MDR key 20745109

Device

Generic name

Regulator, Pressure, Gas Cylinder

Model number

MNDR-600

Patient

NA · Prefer Not To Disclose

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

EVENT 1 [REDACTED DATE]: "BRINGING A CODE CART TO SKILLS DAY EVENT NOTICED THE OXYGEN TANK THAT WAS ATTACHED HAD A PSI READING OF 2491. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING, TANK WAS FLAGGED AND SENT BACK TO (B)(4)". EVENT 2 [REDACTED DATE]: "NEW TANK CAME IN WITH A PSI READING OF 2406 PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING, TANK WAS FLAGGED AND SENT BACK TO (B)(4)". EVENT 3 [REDACTED DATE]: "PEDIATRIC CODE CART WITH AN OXYGEN TANK PSI READING OF 2521. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING, TANK WAS FLAGGED AND SENT BACK TO (B)(4)". MANUFACTURER RESPONSE FOR OXYTOTE, OXYTOTE (PER SITE REPORTER) ONGOING ISSUE.