FDA Adverse Event Malfunction Summary report: N

OXYTOTE

MDR report key: 19228861 · Received May 2, 2024

Report

Report Number
19228861
Event Type
Malfunction
Date Received
May 2, 2024
Date of Event
March 28, 2024
Report Date
April 3, 2024
Manufacturer
WESTERN/SCOTT FETZER COMPANY
Product Code
CAN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

EVENT #1 [REDACTED DATE]: LOCATION: CT SCAN: THIS IS USER ERROR BUT INHERENT TO THE DEVICE THAT PUTS STAFF AND PATIENTS AT RISK. THIS OCCURS DESPITE ONGOING EDUCATION. PATIENT CAME TO CT DEPT WITH OXYGEN TANK OFF. PATIENT ARRIVED IN DEPT AND STATED SHE WAS HAVING PROBLEMS BREATHING. WHEN I CHECKED HER TANK, I NOTICED SHE WAS ON 4L, AND HER TANK WAS TURNED OFF. I QUICKLY TURNED THE TANK ON, AND THE PATIENT SEEMED TO IMPROVE. A MOMENT LATER THE PATIENT STATED SHE WAS BREATHING EASIER. EVENT #2 [REDACTED DATE]: FAULTY GAUGE, LOCATION CARDIOLOGY UNIT, OXYTOTE TANK DISPLAYED "FULL" ON THE SCREEN, BUT ONCE TURNED ON IT BEEPED CONTINUOUSLY AND FLASHED LIGHTS AS IF EMPTY. TANK WAS TAKEN OUT OF SERVICE AND TAGGED FOR (B)(4) TO PICK UP. EVENT #3 [REDACTED DATE]: LOCATION CARDIOLOGY UNIT: OXTOTE WAS TAKEN FROM OXYGEN CABINET READING "FULL" TO BE USED AT A CODE. UPON TANK BEING TURNED ON IT SHOWED A PSI OF 1200. IT THEN STARTED ALARMING AS IF EMPTY. ALTHOUGH TANK GAUGE READ "FULL", IT APPARENTLY WAS NOT. TANK WILL BE RETURNED TO (B)(4). (B)(4) IS OUR OXYGEN DISTRIBUTOR. THE ABOVE MALFUNCTION IS RELATED TO A KNOWN RECALL/NOTICE ISSUED BY WESTERN. THESE REMAIN FAULTY IN OUR CLINICAL FIELDS. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN DELIVERY GAUGE, OXYTOTE (PER SITE REPORTER). THIS SAFETY NOTICE WAS ISSUED BY WESTERN BUT THEY GAUGES REMAIN FAULTY IN OUR FIELD OVER A YEAR LATER AND ARE TOLD THEY WILL NOT GET TO REPAIR THE ENTIRETY OUR FLEET FOR OVER A YEAR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
438370 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other