MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-03 for AMSORB PLUS N/A * manufactured by Armstrong Medical.
[16639405]
This report involves the amsorb co2 filter on two of our anesthesia machines. The part that monitors the co2 levels indicated that the inspired co2 was increasing during a surgery. Biomed discovered after investigating that the problem was the ambsorb container. (this product turns from white to violet when used, but in this case the product was still white. ) biomed looked at the canisters on all the machines and found one other failure where the device was not working as intended. The biomed tech noted that the two malfunctioning canisters had the same lot number. All products with that lot number at our facility were pulled off the shelf. The company has been contacted and they will be receiving the malfunctioning canisters for investigation. ====================== manufacturer response for carbon dioxide absorbent, amsorb plus======================they will be testing the device
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1338494 |
| MDR Report Key | 1338494 |
| Date Received | 2009-03-03 |
| Date of Report | 2009-03-03 |
| Date of Event | 2009-02-19 |
| Report Date | 2009-03-03 |
| Date Reported to FDA | 2009-03-03 |
| Date Added to Maude | 2009-03-11 |
| 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 | BSF |
| Date Received | 2009-03-03 |
| Returned To Mfg | 2009-02-20 |
| Model Number | N/A |
| Catalog Number | * |
| Lot Number | 220908F21 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMSTRONG MEDICAL |
| Manufacturer Address | 13 RED FOX LANE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-03 |