FDA Adverse Event Malfunction Summary report: N

OXYTOTE

MDR report key: 19248035 · Received May 6, 2024

Report

Report Number
19248035
Event Type
Malfunction
Date Received
May 6, 2024
Date of Event
March 6, 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

[REDACTED DATE] [REDACTED NAME] TRANSPORT DEPARTMENT: SITUATION: PATIENT WAS ABOUT TO BE TAKEN OFF THE UNIT WITH AN ALARMING, EMPTY O2 TANK. BACKGROUND: PATIENT IS O2 DEPENDENT. PATIENT WAS BEING TAKEN OFF WT6 TO HD BY TRANSPORTER "LT". AS HE WAS ROLLING OFF THE UNIT, NM, BA, AND ANOTHER RN HEARD THE ALARMING O2 TANK AND STOPPED HIM. ASSESSMENT: THE TRANSPORTER HAD NO IDEA WHAT WE WERE TALKING ABOUT OR WHAT TO DO IF A TANK IS ALARMING. WE CHANGED THE TANK AND EDUCATED HIM ON PSI TIME, TICKET TO RIDE, AND ALARMS. WAS EDUCATED TO REMEMBER THAT O2 IS MEDICINE. THE TANK HAD ZERO O2 IN IT. RECOMMENDATION: EDUCATION TO TRANSPORTER REGARDING O2 SAFETY AND AWARENESS. [REDACTED DATE] [REDACTED NAME] RESPIRATORY THERAPY DEPARTMENT: OXYTOTE PRESSURE INACCURATE. A NEW OXYTOTE O2 CYLINDER/REGULATOR SYSTEM WAS FOUND DISPLAYING "PSI HHHH" WHEN CLOSED AND PSI 3.695 WHEN OPEN. THE INACCURATE PSI DISPLAY PREVENTS THE DEVICE FROM BEING PLACED INTO SERVICE DUE TO THE UNKNOWN/ACTUAL CONTENTS OF THE CYLINDER BEING AVAILABLE. THIS DEVICE NEEDS TO BE REPORTED TO THE VENDOR/MANUFACTURER FOR REVIEW AND POSSIBLY THE FDA. THIS IS RELATED TO A SAFETY NOTICE WAS ISSUED BY WESTERN BUT THEIR 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. MANUFACTURER RESPONSE FOR DIGITAL OXYGEN 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
776194 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown