MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-11-12 for ALARIS 8300 ETCO2 MODULE FIAL8120 manufactured by Alaris Medical Systems, Inc..
| Report Number | 3007409280-2019-00095 |
| MDR Report Key | 9312407 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-11-12 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-10-16 |
| Date Added to Maude | 2019-11-12 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNA VARGAS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer Phone | 8004495328 |
| Manufacturer G1 | AVANTE HEALTH SOLUTIONS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALARIS 8300 ETCO2 MODULE |
| Generic Name | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 |
| Product Code | CCK |
| Date Received | 2019-11-12 |
| Returned To Mfg | 2019-10-21 |
| Model Number | FIAL8120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALARIS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10221 WATERIDGE CIR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-12 |