MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for AMVEX MINI CLICK STYLE GAS REGULATOR ER-GRM2-870RM-T manufactured by Ohio Medical, Llc.
[141375016]
During normal use, device suddenly started flowing high pressure oxygen out of the pressure relief hole. This is one of multiple reports you will receive for the same model (different serial numbers) device with exactly the same failure. Mfr was notified multiple times with acknowledgement that a problem exists. Replacement units also failed. Device click knob also was not secure. Routinely came off of device. Oxygen tubing nipple also not secure. We constantly experienced the nipple separating from the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085653 |
| MDR Report Key | 8495940 |
| Date Received | 2019-04-08 |
| Date of Report | 2018-08-11 |
| Date Added to Maude | 2019-04-09 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMVEX MINI CLICK STYLE GAS REGULATOR |
| Generic Name | PORTABLE OXYGEN REGULATOR / REGULATOR VACUUM |
| Product Code | KDP |
| Date Received | 2019-04-08 |
| Model Number | ER-GRM2-870RM-T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL, LLC |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |