MalfunctionCAN

WESTERN/SCOTT FETZER

Received May 12, 2025 · Event occurred Apr 30, 2025

Report 22001593 · MDR key 22001593

Device

Generic name

Regulator, Pressure, Gas Cylinder

Manufacturer

Western Enterprises

Model number

MNDR-600

Catalog number

MNDR-600

Product problems

Incorrect, Inadequate or Imprecise Result or Readings
Defective Component

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

EVENT 1 [REDACTED]: OXYTOTE WAS NOT ON THE PATIENT WHEN THE GAUGE MISREAD. EVENT 2 [REDACTED]: OXYTOTE GAUGE IS MISREADING. ALSO, THE ON/OFF KNOB IS SPINNING COMPLETELY AROUND. MANUFACTURER RESPONSE FOR OXYTOTE, OXYTOTE (PER SITE REPORTER). ONGOING ISSUES.