MalfunctionCAN

OXYTOTE

Received Jul 11, 2024 · Event occurred May 31, 2024

Report 19719144 · MDR key 19719144

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]: NEW TANK CAME IN WITH A PSI READING OF 2800. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(6), OUR GAS DISTRIBUTOR WHO WILL SEND TO WESTERN/MFG. EVENT #2 [REDACTED DATE]: NEW TANK CAME IN WITH A PSI READING OF 1600. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(6), OUR GAS DISTRIBUTOR WHO WILL SEND TO WESTERN/MFG. EVENT #3: TANK FOUND ON CODE CART WITH A PSI READING OF 2267. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(6), OUR GAS DISTRIBUTOR WHO WILL SEND TO WESTERN/MFG. THESE EVENTS ARE PART OF A MANUFACTURER RECALL THAT DID NOT INVOLVE PRODUCT REMOVAL. MANUFACTURER RESPONSE FOR OXYGEN DIGITAL GAUGE, OXYTOTE (PER SITE REPORTER).