MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-05 for AMSORB PLUS * AMAB3200 manufactured by Armstrong Medical Limited.
[343791]
Amsorb in bottom of an anesthesia breathing circuit was not absorbing co2 and did not change color as it is supposed to. Indicated by high inspiratory co2 alarm and reading of 13 mmhg, which was corrected by inserting a new amsorb canister. It was being used in a datex-ohmeda mod se anesthesia machine with a gms breathing system. The top canister had turned 90% violet as it should when capacity is used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034128 |
| MDR Report Key | 563848 |
| Date Received | 2004-11-05 |
| Date of Report | 2004-11-05 |
| Date of Event | 2004-11-05 |
| Date Added to Maude | 2005-01-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSORB PLUS |
| Generic Name | CO2 ABSORBENT FOR ANESTHESIA BREATHING CIRCUIT |
| Product Code | CBL |
| Date Received | 2004-11-05 |
| Model Number | * |
| Catalog Number | AMAB3200 |
| Lot Number | PROBABLY 260104F12 |
| ID Number | * |
| Device Expiration Date | 2006-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 553577 |
| Manufacturer | ARMSTRONG MEDICAL LIMITED |
| Manufacturer Address | * COLERAINE, NORTHERN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-05 |