MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2018-11-27 for EQUINOX RELIEVE 01EQ1000 manufactured by O-two Medical Technologies Inc..
[129330870]
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.
Patient Sequence No: 1, Text Type: N, H10
[129330871]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610861-2018-00001 |
| MDR Report Key | 8105750 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-04-20 |
| Device Manufacturer Date | 2014-03-18 |
| Date Added to Maude | 2018-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID ZHANG |
| Manufacturer Street | 45A ARMTHORPE ROAD |
| Manufacturer City | BRAMPTON, ONTARIO L6T 5M4 |
| Manufacturer Country | CA |
| Manufacturer Postal | L6T 5M4 |
| Manufacturer G1 | 9610861 |
| Manufacturer Street | 45A ARMTHORPE ROAD |
| Manufacturer City | BRAMPTON, ONTARIO L6T 5M4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L6T 5M4 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9610861-5/10/2018-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUINOX RELIEVE |
| Generic Name | N2O/O2 MIXER |
| Product Code | BZR |
| Date Received | 2018-11-27 |
| Returned To Mfg | 2018-04-24 |
| Model Number | 01EQ1000 |
| Catalog Number | 01EQ1000 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | O-TWO MEDICAL TECHNOLOGIES INC. |
| Manufacturer Address | 45A ARMTHORPE ROAD BRAMPTON, ONTARIO L6T 5M4 CA L6T 5M4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-27 |