MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for FABIUS GS PREMIUM NA manufactured by Draeger Medical Systems Inc..
[109402444]
Patient is a (b)(6) year old female that came in for a sleeve gastrectomy. Pt in the operating room the anesthetic vaporizer was turned in the "on" position but it was not delivering any volatile gases. The vaporizer and machine was evaluated. It was found that the vaporizer was full and should have been delivering the gas to the patient. The patient recalls periods of the surgery. The machine and vaporizer was removed from circulation and immediately went for investigation. Dates of use: (b)(6) 2018. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077451 |
| MDR Report Key | 7544291 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-08 |
| Date Added to Maude | 2018-05-25 |
| 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 |
| 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 | FABIUS GS PREMIUM |
| Generic Name | GAS-MACHINE ANESTHESIA |
| Product Code | BSZ |
| Date Received | 2018-05-24 |
| Model Number | FABIUS GS PREMIUM |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS INC. |
| Brand Name | VAPOR 2000 D |
| Generic Name | VAPORIZSER, ANESTHESIA, NON-HEATED |
| Product Code | CAD |
| Date Received | 2018-05-24 |
| Model Number | VAPOR 2000-D |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-24 |