MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-24 for CLIC ABSORBER 800+ MX00004 manufactured by Draeger Medical, Inc..
[2511118]
A fresh co2 absorber canister was installed in the anesthesia machine. Anesthesia machine checked ok, but during use it continually announced a "fresh gas low" alarm. Clinician was able to adjust machine settings to maintain correct patient ventilation. When case was ended, problem was reported to biomed techs. Upon investigation, a fault within the absorber canister was identified which allowed soda lime pellets to partially fill the canister's central air inlet tube, greatly reducing air flow. The anesthesia machine worked properly once a new canister was installed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430881 |
| MDR Report Key | 2430881 |
| Date Received | 2012-01-24 |
| Date of Report | 2012-01-24 |
| Date of Event | 2012-01-20 |
| Report Date | 2012-01-24 |
| Date Reported to FDA | 2012-01-24 |
| Date Added to Maude | 2012-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLIC ABSORBER 800+ |
| Generic Name | CO2 ABSORBER CARTRIDGE, 1.2L DISPOSABLE |
| Product Code | BSF |
| Date Received | 2012-01-24 |
| Model Number | 800+ |
| Catalog Number | MX00004 |
| Lot Number | ARCM F006 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL, INC. |
| Manufacturer Address | 3135 QUARRY RD TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-24 |