MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-10 for AMSORB PLUS G-CAN * manufactured by Armstrong Medical Ltd.
[1788955]
Anesthesia machine alarmed that there was an air leak. Clinical engineering investigated. Found small pin holes in canisters (amsorb plus g-can co2 absorbent canister) with one lot number. Inventory with this lot number was removed from stock room and anesthesia machines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1945135 |
| MDR Report Key | 1945135 |
| Date Received | 2010-12-10 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-12-08 |
| Report Date | 2010-12-09 |
| Date Reported to FDA | 2010-12-10 |
| Date Added to Maude | 2011-01-03 |
| 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 | AMSORB PLUS |
| Generic Name | CARBON DIOXIDE ABSORBENT |
| Product Code | CBL |
| Date Received | 2010-12-10 |
| Model Number | G-CAN |
| Catalog Number | * |
| Lot Number | 19071F11 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMSTRONG MEDICAL LTD |
| Manufacturer Address | 7549 SPRING LAKE DR. NO. C-2 BETHESDA MD 20817 US 20817 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-10 |