MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-07 for VAPORIZER M35170 manufactured by Draeger Medical Systems, Inc..
[76851736]
Patient Sequence No: 1, Text Type: N, H10
[76851737]
It was reported that after intravenous induction of general anesthesia for a patient undergoing biliary endoscopy, patient was reportedly placed on a ventilator and subsequently received sevoflurane. A sevoflurane expired level was reportedly not visible on the patient monitor. Attempts were then made to "trouble shoot" the monitor. Procedure was started after which fentanyl and propofol were administered. A portable gas analyzer reportedly confirmed no sevoflurane level. A new sevoflurane vaporizer was then placed on the anesthesia machine after which a sevoflurane level appeared on the monitor. Sevoflurane was then administered as the anesthetic. Procedure was completed without incident; however patient reported awareness under anesthesia after completion. Patient denied having any pain during the procedure. Continued follow up with the patient is planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6618182 |
| MDR Report Key | 6618182 |
| Date Received | 2017-06-07 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-05-09 |
| Report Date | 2017-05-19 |
| Date Reported to FDA | 2017-05-19 |
| Date Reported to Mfgr | 2017-05-19 |
| Date Added to Maude | 2017-06-07 |
| 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 |
| 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 | VAPORIZER |
| Generic Name | VAPORIZER, ANESTHESIA, NON-HEATED |
| Product Code | CAD |
| Date Received | 2017-06-07 |
| Model Number | M35170 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 6 TECH DR. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-07 |