MAUDE Adverse Event Report: O-TWO MEDICAL TECHNOLOGIES INC. EQUINOX RELIEVE; N2O/O2 MIXER

Model Number 01EQ1000

Device Problems High Readings (2459); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

This is a reporting of a complaint (device malfunction during service) that was received on apr.20, 2018.A voluntary product correction for upgrade was proposed and the correction/removal report has been sent to fda on may 10, 2018.However, emdr has not been filed at that time.

Event Description

On apr.24, 2018 we received two (2) o2/n2o mixers (serial numbers: (b)(4)) which were reported to have delivered higher levels of nitrous oxide than specification during routine testing.Our records show that neither of these units had been returned for service since they were manufactured in 2014.It was reported that there was no patient involvement in either case.As the device is intended to deliver a 50/50% mixture of nitrous oxide and oxygen to a patient, the potential delivery of higher nitrous oxide concentrations which may affect oxygen saturation levels of the patient.However, as the device delivers a self-administered (based on patient demand) a mixture of nitrous oxide and oxygen and it is handheld by the patient and not attached to them, the device would stop supplying gas when the mask to face seal is broken.Hence, the probability of this issue creating a health hazard is, based on our hazard evaluation, extremely low.

• Brand Name: EQUINOX RELIEVE
• Type of Device: N2O/O2 MIXER
• Manufacturer (Section D): O-TWO MEDICAL TECHNOLOGIES INC.; 45a armthorpe road; brampton, ontario L6T 5 M4; CA L6T 5M4
• Manufacturer (Section G): 9610861; 45a armthorpe road; brampton, ontario L6T 5 M4; CA L6T 5M4
• Manufacturer Contact: david zhang ; 45a armthorpe road; brampton, ontario L6T 5-M4 ; CA L6T 5M4
• MDR Report Key: 8105750
• MDR Text Key: 129330870
• Report Number: 9610861-2018-00001
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 01EQ1000
• Device Catalogue Number: 01EQ1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 9610861-5/10/2018-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other