MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-20 for DIAMOND CONNECTOR, N2O * manufactured by Ohio Medical Corporation.
[998593]
We discovered a problem for hospitals using wall provided n2o and co2 gas. We are able to plug the n2o ohio diamond connector into the chemtron model 500 n20 outlet, which it is intended for, but also into the co2 outlet, which it is not intended for. The ohio diamond connector for co2 does not fit in any other gas outlet. The outlets are designed to accept either a chemtron or ohio diamond connector. Labeling the connectors will not help, as the problem can still occur if the connector is turned over and inserted into the wall outlet. We plan to change the n2o connector from ohio diamond to chemtron on all anesthesia machines. The chemtron fitting for n2o can not fit into the co2 wall outlet. ====================== manufacturer response for n2o and co2 connectors, (brand not provided)======================hospital contacted both ohio medical and allied health care to alert them of problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282626 |
| MDR Report Key | 1282626 |
| Date Received | 2008-11-20 |
| Date of Report | 2008-11-20 |
| Date of Event | 2008-11-13 |
| Report Date | 2008-11-20 |
| Date Reported to FDA | 2008-11-20 |
| Date Added to Maude | 2009-01-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMOND CONNECTOR, N2O |
| Generic Name | CONNECTOR, TUBING |
| Product Code | CAM |
| Date Received | 2008-11-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | DIRECTOR OF REGULATORY AFFAIRS 1111 LAKESIDE DRIVE GURNEY IL 60031 US 60031 |
| Brand Name | CHEMETRON WALL OUTLET |
| Generic Name | WALL OUTLET, GAS |
| Product Code | CAM |
| Date Received | 2008-11-20 |
| Model Number | 500 SERIES |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVENUE ST. LOUIS OH * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-20 |