MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-01 for AMSORB PLUS manufactured by Armstrong Medical, Ltd.
[50882790]
Patient Sequence No: 1, Text Type: N, H10
[50882791]
Using new amsorb cannisters of anesthesia absorbant. Multiple providers have reported difficulty using the cannisters of absorbant in the drager apolloa anesthesia machine absorbant holder. Manufacturer response for disposable anesthesia absorbant cannister, amsorg (per site reporter): took info, will look into it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5837278 |
| MDR Report Key | 5837278 |
| Date Received | 2016-08-01 |
| Date of Report | 2016-07-13 |
| Date of Event | 2016-07-11 |
| Report Date | 2016-07-13 |
| Date Reported to FDA | 2016-07-13 |
| Date Reported to Mfgr | 2016-07-13 |
| Date Added to Maude | 2016-08-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSORB PLUS |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2016-08-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-08-01 |