MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for REGULATOR, PRESSURE, GAS CYLINDER manufactured by Airgas Usa.
[131503015]
On (b)(6) 2018, service technician discovered odor at carbon dioxide gas manifold coming from one cylinder. Co2 outlets were tested. Tests indicated elevated levels of hydrocarbons in the co2 line, not meeting nfpa99 standards. Co2 regulator and parts of manifold were found damaged and were replaced. Co2 was used during laparoscopic surgery for insufflation or during cardiovascular surgery for oxygen displacement/surgical fire prevention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082469 |
| MDR Report Key | 8190777 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-23 |
| Date of Event | 2018-07-09 |
| Date Added to Maude | 2018-12-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Brand Name | REGULATOR, PRESSURE, GAS CYLINDER |
| Generic Name | REGULATOR, PRESSURE, GAS CYLINDER |
| Product Code | CAN |
| Date Received | 2018-12-20 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRGAS USA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-20 |