FDA Adverse Event Malfunction Summary report: N

OXYTOTE

MDR report key: 19228642 · Received May 2, 2024

Report

Report Number
19228642
Event Type
Malfunction
Date Received
May 2, 2024
Date of Event
April 10, 2024
Report Date
April 22, 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: DEFECTIVE OXYTOTE GAUGE READING IN ED TANK. TANK GAUGE WAS READING INCORRECTLY AND ALARMING. GAUGE IS DISPLAYING TWO DIFFERENT READINGS. TANK WAS TAKEN OUT OF SERVICE AND TAGGED TO BE RETURNED TO GAS COMPANY. THIS IS RELATED TO A SAFETY NOTICE 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. EVENT #2 (SAME DATE): PATIENT WAS BEING TRANSPORTED TO ULTRASOUND. HE WAS ON 2-3L NC. PATIENT WAS PLACED ON THE PORTABLE TANK FOR TRANSPORT. THE TANK WAS TURNED TO 3L BUT, THE TANK WAS NOT SWITCHED TO "ON" DURING TRANSPORT. PATIENT RETURNED TO TREATMENT ROOM WITH OXYGEN SATURATION 86-88% ON ROOM AIR. HE WAS PLACED BACK ON NASAL CANNULA AT THAT TIME AND HIS OXYGEN SATURATION IMPROVED. WHILE THIS IS RELATED TO USER ERROR, ITS DESIGN OF A TWO STEP TURN-ON PROCESS (NORMALLY ONE STEP WITHOUT GAUGE) CONTRIBUTES TO MANY FAILURES TO DELIVER OXYGEN. MANUFACTURER RESPONSE FOR OXYGEN GAUGE, OXYTOTE (PER SITE REPORTER). THIS IS RELATED TO A SAFETY NOTICE 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
402732 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown