MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for AMVEX INTEGRATED FLOWMETER FI-T15UO-DN-E manufactured by Ohio Medical Llc.
[136977570]
Ohio medical has been in continuous contact with the user facility and are awaiting final results of their investigation into this incident. As part of their internal investigation, ohio medical has also consulted with a 3rd party clinical consultant, who currently serves as department chair of cardiopulmonary and respiratory care program director at (b)(6) medical center, and it is strongly believed that, since the device was never observed having a "no flow" failure or lack of oxygen flow this device did not cause or contribute to the patient death. Additional information will continue to be gathered, as ohio medical is waiting on confirmation from the user facility that ifus and preventive maintenance protocols were followed. Subsequent follow up reports will be submitted to the fda in a timely manner.
Patient Sequence No: 1, Text Type: N, H10
[136977571]
On january 22, 2019 ohio medical received report of an incident involving an alleged failure that the integrated flowmeter was not performing to specification during a patient code event. Device was returned to ohio medical for evaluation on february 5, 2019. Evaluation results shown below: no visual defects observed (i. E. No cracks, no visible damage). Unit was tested for supply side leak, no leaks observed. Unit was tested for patient side leak, no leaks observed. Unit set to 1lpm, unit reading was 1. 4lpm. Unit was set to 3lpm, unit reading was 3. 3lpm. Unit was set to 5lpm, unit reading was 5. 9lpm. Unit was set to 10lpm, unit reading was 11. 6lpm. Unit set to 15lpm, unit reading was 18. 4lpm. When flow control knob was fully turned clockwise to set to maximum flow it was observed that the flow would increase and then lower and stabilize at 12. 2lpm. The ohio medical test results conclude that while flow accuracy did not perform to specification oxygen flow was always being delivered and was in excess of the flow setting, except for when maximum flow rate was desired. At the maximum flow rate setting the unit would increase and then lower and stabilize at 12. 2lpm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2019-00001 |
| MDR Report Key | 8364558 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-01-20 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2017-03-15 |
| Date Added to Maude | 2019-02-22 |
| 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 | MS. JESSICA BARRILE |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478556318 |
| Manufacturer G1 | OHIO MEDICAL LLC |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60031 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMVEX INTEGRATED FLOWMETER |
| Generic Name | INTEGRATED FLOWMETER |
| Product Code | CAX |
| Date Received | 2019-02-22 |
| Returned To Mfg | 2019-02-05 |
| Model Number | FI-T15UO-DN-E |
| Catalog Number | FI-T15UO-DN-E |
| Lot Number | 0758 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL LLC |
| Manufacturer Address | 1111 LAKESIDE DR GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-02-22 |