MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for AMSORB PLUS G-CAN 2105489-003 manufactured by Armstrong Medical, Ltd..
[136501203]
Biomedical responded on service call up to determine reason for anesthesia circuit leak test failure. Inspection of the anesthesia machine noted a pronounced crack on the forward side of the disposable co2 absorber canister just below the front compensation tube. Biomedical noted that this was the second occurrence of cracking in this section of the canister in the last two weeks. Because of the location of the crack it was determined that this was not impact damage due to the location of the absorber as it was nested in the absorber/patient circuit assembly. This section of the absorber was protected by a condenser assembly that would have prevented any impact damage. Damaged absorber retrieved to have manufacturer analyze reason for cracking. Manufacturer response for disposable prefill absorber canister, amsorb plus g-can (per site reporter). Awaiting manufacturer response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8349438 |
| MDR Report Key | 8349438 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-02-11 |
| Report Date | 2019-02-12 |
| Date Reported to FDA | 2019-02-12 |
| Date Reported to Mfgr | 2019-02-19 |
| Date Added to Maude | 2019-02-19 |
| 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 | 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 G-CAN |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2019-02-19 |
| Catalog Number | 2105489-003 |
| Lot Number | 091018F21 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMSTRONG MEDICAL, LTD. |
| Manufacturer Address | 575 KNIGHTSBRIDGE PKWY LINCOLNSHIRE IL 60069 US 60069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |