MalfunctionCAN

OXYTOTE

Received Aug 8, 2024 · Event occurred Jul 1, 2024

Report 19937444 · MDR key 19937444

Device

Generic name

Regulator, Pressure, Gas Cylinder

Manufacturer

Western/scott Fetzer Co.

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 2306. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4), DISTRIBUTOR WHO WILL SEND TO WESTERN (MFG) FOR REPAIR. EVENT #2 [REDACTED DATE] TANK FOUND ON THE FLOORS, REGULATOR FLASHING BETWEEN OF/OF AND E1OE. PROBLEM WITH TANKS REGULATOR. TANK WAS FLAGGED AND SENT BACK TO (B)(4), DISTRIBUTOR WHO WILL SEND TO WESTERN (MFG) FOR REPAIR. EVENT #3 [REDACTED DATE]: NEW TANK CAME IN WITH A PSI READING OF 2372. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4), DISTRIBUTOR WHO WILL SEND TO WESTERN (MFG) FOR REPAIR. EVENT #4 [REDACTED DATE]: NEW TANK CAME IN WITH A PSI READING OF 2687. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4), DISTRIBUTOR WHO WILL SEND TO WESTERN (MFG) FOR REPAIR. EVENT #5 [REDACTED DATE]: NEW TANK CAME IN WITH A PSI READING OF 3102. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4), DISTRIBUTOR WHO WILL SEND TO WESTERN (MFG) FOR REPAIR. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER).