inforMED
MalfunctionCAN

OXYTOTE

Received Jul 23, 2024 · Event occurred Jun 7, 2024

Report 19804755 · MDR key 19804755

Device

Generic name

Regulator, Pressure, Gas Cylinder

Model number

MNDR-600

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

EVENT 1 [REDACTED DATE]: "NEW TANK CAME IN WITH A PSI READING OF 1724. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." EVENT 2 [REDACTED DATE]: "TANK FOUND ON THE FLOOR WITH READING "HHHH" PROBLEM WITH TANKS REGULATOR. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." EVENT 3 [REDACTED DATE]: "TANK SOUND WITH A PSI READING OF 2720 AND THEN FLASHING TO "OF ER". PROBLEM WITH TANKS REGULATOR. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." EVENT 4 [REDACTED DATE]: "NEW TANK CAME IN WITH A PSI READING OF 2302. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." MANUFACTURER RESPONSE FOR OXYTOTE TANK, OXYTOTE TANK (PER SITE REPORTER), ONGOING ISSUE WITH OXYTOTE TANKS.