MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-31 for EVOLUTION OXYGEN CONSIVERATOR REGULATOR EVOLUTION OM-900 manufactured by Chad/drive Inovo, Inc.
[4099624]
I require oxygen 24/7 and utilize portable tanks and a chad/drive evolution model om-900 pulse oxygen conservator device when i am away from my house. This device (sn (b)(4)) became intermittent and failed to provide oxygen in the pulse mode. I did not realize that the device was malfunctioning while i was walking until i was severely de-saturated and about to pass out. Rapping the regulator with my knuckles would temporarily restore the functionality of the regulator but a few minutes later, the regulator would again cease to function. This is now the third (3rd) chad om-900 regulator that has failed for me with an identical intermittent condition in the past year and needed to be replaced by my oxygen provider. I have contacted my oxygen provider ((b)(4)) for a replacement regulator but i believe the repetitive failure of this model regulator is dangerous and a significant quality issue that needs to be addressed. I want to bring this matter to your attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033691 |
| MDR Report Key | 3554149 |
| Date Received | 2013-12-31 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-28 |
| Date Added to Maude | 2014-01-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION OXYGEN CONSIVERATOR REGULATOR |
| Generic Name | EVOLUTION OXYGEN CONSIVERATOR REGULATOR |
| Product Code | NFB |
| Date Received | 2013-12-31 |
| Model Number | EVOLUTION OM-900 |
| ID Number | P/N AL-00156/12/C |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHAD/DRIVE INOVO, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-12-31 |