MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-24 for GENERAL ELECTRIC AISYS 5 manufactured by General Electric.
[1734469]
During process to administer anesthesia gas to intubated pt, it was noted that the anesthesia machine -aisys 5/ge- would not administer the agent. The safety program had been updated/installed the evening prior to this event without any indication that agents would not turn on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019130 |
| MDR Report Key | 1972643 |
| Date Received | 2011-01-24 |
| Date of Report | 2011-01-24 |
| Date of Event | 2011-01-13 |
| Date Added to Maude | 2011-02-01 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENERAL ELECTRIC |
| Generic Name | AISYS 5 |
| Product Code | CBR |
| Date Received | 2011-01-24 |
| Model Number | AISYS 5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENERAL ELECTRIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-01-24 |