MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-01 for FABIUS G S ANESTHESIA MACHINE FABIUS SG manufactured by Draeger Medical, Inc.
[17019354]
We had a broken flowmeter on a draeger anesthesia machine. This resulted in a huge leak in the anesthesia breathing circuit. The anesthetist was unable to ventilate the pt until an ambu bag portable ventilator could be acquired. There was no injury to the pt, but the potential was there. We have now found out that draeger knew there was a problem several years ago, and produced a repair. We were never notified of the defect, or the availability of the repair kit. We would like some follow up on this to find out what went wrong in order to avoid future problems in communication. Dates of use: (b) (6) 2006 - (b) (6) 2010. Diagnosis: ventilator spirometer for the anesthesia machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014980 |
| MDR Report Key | 1623550 |
| Date Received | 2010-03-01 |
| Date of Report | 2010-03-01 |
| Date of Event | 2010-01-20 |
| Date Added to Maude | 2010-03-12 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FABIUS G S ANESTHESIA MACHINE |
| Generic Name | FLOWMETER OR SPIROMETER |
| Product Code | CAX |
| Date Received | 2010-03-01 |
| Model Number | FABIUS SG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL, INC |
| Manufacturer Address | TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2010-03-01 |