FDA Adverse Event Malfunction Summary report: N

OXYTOTE

MDR report key: 18939808 · Received March 20, 2024

Report

Report Number
18939808
Event Type
Malfunction
Date Received
March 20, 2024
Date of Event
March 1, 2024
Report Date
March 1, 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

OXYTOTE TANKS HAVE BEEN A CHALLENGE FOR OUR INSTITUTION SINCE IMPLEMENTATION IN 2021. WE ARE NOW LEARNING THAT OUR OXYGEN DISTRIBUTOR (B)(4) ALL GAS HAS BEEN SENDING THE DEVICES TO WESTERN (MANUFACTURER OF OXYTOTE) AND INSTALLING A SOFTWARE TO DETECT A GAUGE MALFUNCTION. WE ALSO LEARNED THAT WESTERN DISCONTINUED THIS PRODUCT IN 2022 AND [REDACTED NAME] DID NOT KNOW. WESTERN WAS ABLE TO SOURCE SOME GAUGES FROM THE MANUFACTURER OF THE FAULTY GAUGE BUT DOES NOT KNOW IF THEY HAVE ENOUGH TO REPAIR OUR FLEET OF DEVICES. OVER THE PAST YEAR, THEY HAVE ONLY SERVICED APPROXIMATELY 15% OF THE FLEET, THERE ARE 24K DEVICES MADE IN TOTAL AND [REDACTED NAME] OWNS APPROXIMATELY 7K. WESTERN REPORTED TO [REDACTED NAME] THEY ARE SEEING AN APPROXIMATE FAILURE RATE OF 9% OF THE DEVICES THAT THEY HAVE INTERROGATED THUS FAR. THIS IS RELATED TO A NOTICE WE RECEIVED BY (B)(4) ALL GAS BUT WERE NEVER TOLD OF THE MITIGATION OR CORRECTIVE ACTION AND LEARNED IT ALL IN THE PAST WEEK. EMAILING FILE TO [REDACTED NAME] AS IT WILL NOT PERMIT EXCEL UPLOAD. MANUFACTURER RESPONSE FOR OXYGEN DELIVERY GAUGE, OXYTOTE (PER SITE REPORTER).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1266600 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown