MalfunctionCAN

OXYTOTE

Received Nov 18, 2024 · Event occurred Sep 27, 2024

Report 20705440 · MDR key 20705440

Device

Generic name

Regulator, Pressure, Gas Cylinder

Manufacturer

Western Enterprises

Model number

MNDR-600

Catalog number

MNDR-600

Lot number

N/A

Patient

NA · Prefer Not To Disclose

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

Narrative

Description of Event or Problem

EVENT 1 (REDACTED DATE) MFG: WESTERN CODE: OXYTOTE MNDR-600. "NEW TANK CAME IN WITH A PSI READING OF 0. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING CODE E10E. TANK WAS FLAGGED AND SENT BACK TO (B)(4)". EVENT 2 (REDACTED DATE) MFG: WESTERN CODE: OXYTOTE MNDR-603. "NEW TANK CAME IN WITH A PSI READING OF 2468. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4)". EVENT 3 (REDACTED DATE) MFG: WESTERN CODE: OXYTOTE MNDR-602. "TANK FOUND ON INTERMEDIATE CARE STORE ROOM WITH PSI READING OF 2538. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4)". EVENT 4 (REDACTED DATE) MFG: WESTERN CODE: OXYTOTE MNDR-601. "NEW TANK CAME IN WITH A PSI READING OF 2300. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4)". EVENT 5 (REDACTED DATE) MFG: WESTERN CODE: OXYTOTE MNDR-600 "NEW TANK CAME IN WITH A PSI READING OF 8888 PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING TANK WAS FLAGGED AND SENT BACK TO (B)(4)". MANUFACTURER RESPONSE FOR OXYTOTE, OXYTOTE (PER SITE REPORTER). ONGOING ISSUE.