MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-15 for ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C) ADVIA CHEMISTRY CARBON DIOXIDE CONCENTRATED 10283345 manufactured by Siemens Healthcare Diagnostics Inc..
| Report Number | 2432235-2019-00293 |
| MDR Report Key | 8897854 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-08-15 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-07-23 |
| Date Mfgr Received | 2019-08-22 |
| Date Added to Maude | 2019-08-15 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MIR KHAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10951 |
| Manufacturer Country | US |
| Manufacturer Postal | 10951 |
| Manufacturer Phone | 9145243074 |
| Manufacturer G1 | SEKISUI DIAGNOSTICS PEI INC. |
| Manufacturer Street | 70 WATTS AVENUE REGISTRATION # 8020316 |
| Manufacturer City | CHARLOTTETOWN, PE C1E 2B9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | C1E 2B9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C) |
| Generic Name | ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C) |
| Product Code | KHS |
| Date Received | 2019-08-15 |
| Model Number | ADVIA CHEMISTRY CARBON DIOXIDE CONCENTRATED |
| Catalog Number | 10283345 |
| Lot Number | 050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10951 US 10951 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-15 |