MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-17 for AMVEX FI-T15UO-DN-E manufactured by Ohio Medical Llc.
[83221575]
Device has been evaluated, follow up report will be submitted with results of evaluation and further investigation within 30 days.
Patient Sequence No: 1, Text Type: N, H10
[83221576]
Complaint was received stating the following: we had a failure of one of the integrated oxygen outlets in our new cancer hospital today. We had another flowmeter servicing an ambu bag on the auxiliary diss outlet. Somehow while the janitor was removing the o2 tubing from flowmeter the auxiliary outlet became separated from the integrated flowmeter body. When this occurred, oxygen at 50 psi was discharging into the room causing great alarm to all those nearby. The oxygen zone valve to that side of the floor was shut off and the integrated flowmeter was removed. The oxygen to the floor was turned back on and the project manager is ordering some spare / replacement integrated flowmeters. The retention ring that holds the auxiliary outlet in place, must have not been installed properly or experienced some type of failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617620-2017-00001 |
| MDR Report Key | 6800062 |
| Date Received | 2017-08-17 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-07-22 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2017-02-15 |
| Date Added to Maude | 2017-08-17 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 G1 | OHIO MEDICAL LLC |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMVEX |
| Generic Name | INTEGRATED FLOWMETER |
| Product Code | CAX |
| Date Received | 2017-08-17 |
| Returned To Mfg | 2017-06-23 |
| Model Number | FI-T15UO-DN-E |
| Catalog Number | FI-T15UO-DN-E |
| Lot Number | 0748 |
| Operator | RESPIRATORY THERAPIST |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-08-17 |