MalfunctionCAN

OXYTOTE

Received Jul 11, 2024 · Event occurred Jun 9, 2024

Report 19719159 · MDR key 19719159

Device

Generic name

Regulator, Pressure, Gas Cylinder

Manufacturer

Western/scott Fetzer Co.

Model number

MNDR-600

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

EVENT #1 [REDACTED DATE]: OXYTOTE GAUGE READING TOO HIGH (2546 PSI). EVENT #2 [REDACTED DATE]: OXYTOTE OXYGEN TANK - GAUGE FLASHING BETWEEN TWO DIFFERENT READINGS. CAN'T GET AN ACCURATE READ ON TANK. TANK WAS TAGGED "DEFECTIVE" TO RETURN TO (B)(6) (OUR OXYGEN DISTRIBUTOR WHO WILL SEND TO WESTERN/MFG FOR REPAIR). THESE EVENTS ARE PART OF AN EXISTING RECALL NOTIFICATION THAT DID NOT INVOLVE PRODUCT REMOVAL. MANUFACTURER RESPONSE FOR OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER).