MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-30 for AMSORB PLUS CAN-CAN ABSORBER * AMAB3800 manufactured by Armstrong Medical Limited.
[466031]
The amsorb can-can absorber is marketed as a substitue for the ge disposable multi absorber, ref 8003138. We have been using them with the ge aisys anesthesia machine. In several instances, we have encountered extreme difficulty mounting the amsorb unit on the aisys machine. It would appear that inside diameter of the water trap portion (and possibly the other ports) are too small, making it difficult to attach and possibly damaging the o-ring. Comparing of the amsorb canister to the ge canister, the o-ring that seals the water trap is visibly much more compressed by the amsorb canister. In addition, we have had problems with the canister becoming dislodged during use. The lugs that hold the canister in place appear to be shorter than the ge version, contributing to the problem. In several cases, the canister "popped off" during the leak test. The diameter of the amsorb canister is also much larger, and touches against part of the anesthesia machine, possibly preventing proper alignment of the ports and locking mechanism. The device is suspected of causing circuit leaks in some cases. It is also possible to mount the canister backward in the machine and this has been observed in one case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 733480 |
| MDR Report Key | 733480 |
| Date Received | 2006-06-30 |
| Date of Report | 2006-06-30 |
| Date of Event | 2006-06-29 |
| Report Date | 2006-06-30 |
| Date Reported to FDA | 2006-06-30 |
| Date Added to Maude | 2006-07-13 |
| 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 CAN-CAN ABSORBER |
| Generic Name | ANESTHESIA ABSORBER |
| Product Code | CBL |
| Date Received | 2006-06-30 |
| Model Number | * |
| Catalog Number | AMAB3800 |
| Lot Number | 100406F31 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 721600 |
| Manufacturer | ARMSTRONG MEDICAL LIMITED |
| Manufacturer Address | REGULATORY INSIGHT 13 RED FOX LANE LITTLETON CO 80127 US |
| Brand Name | AISYS ADU CARESTATION |
| Generic Name | ANESTHESIA MACHINE |
| Product Code | BSZ |
| Date Received | 2006-06-30 |
| Model Number | 1011-9000-000 |
| Catalog Number | 1011-9000-000 |
| Lot Number | NONE |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 721601 |
| Manufacturer | DATEX-OHMEDA, INC |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI 537077550 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-30 |