MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-05 for PRO-NOX CMI-0100-PNX-HS manufactured by Carestream Medical International Ltd.
| Report Number | 8964424 |
| MDR Report Key | 8964424 |
| Date Received | 2019-09-05 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-08-09 |
| Report Date | 2019-08-20 |
| Date Reported to FDA | 2019-08-20 |
| Date Reported to Mfgr | 2019-09-05 |
| Date Added to Maude | 2019-09-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO-NOX |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2019-09-05 |
| Model Number | CMI-0100-PNX-HS |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM MEDICAL INTERNATIONAL LTD |
| Manufacturer Address | 774 S NORTHLAKE BLVD ALTAMONTE SPRINGS FL 32701 US 32701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-05 |