MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-01-23 for CO2 CONNET 2 CHEMETRON OUTLET 64-02-5007 manufactured by Allied Healthcare Products, Inc..
[1070450]
It was reported that the hospital using wall provided n2o and co2 gas had a problem. The hospital was able to plug the n2o ohio diamond connector into the chemetron model 500 connect 2 n2o 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 chemetron 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 chemetron on all anesthesia machines. The chemetron fitting for n2o can not fit into the co2 wall outlet.
Patient Sequence No: 1, Text Type: D, B5
[8174897]
Connect 2 outlets are labeled for the gas they are intended for. (carbon dioxide). Connect 2 outlets are color coded for the gas they are intended for. (gray for carbon dioxide). The only what to make an ohio n2o adapter go into a chemetron co2 connect 2 outlet is to turn it upside down (180 degrees).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1924066-2009-00001 |
| MDR Report Key | 1342634 |
| Report Source | 05,06 |
| Date Received | 2009-01-23 |
| Date of Report | 2009-01-23 |
| Date of Event | 2008-11-13 |
| Date Mfgr Received | 2009-01-20 |
| Date Added to Maude | 2010-01-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1720 SUBLETTE AVE. |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3147712400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO2 CONNET 2 CHEMETRON OUTLET |
| Generic Name | CO2 OUTLET STATION |
| Product Code | CAM |
| Date Received | 2009-01-23 |
| Model Number | 64-02-5007 |
| Catalog Number | 64-02-5007 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | ST. LOUIS MO 63110 US 63110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-23 |