MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for AMSORB PLUS AMAB3801 manufactured by Armstrong Medical Ltd..
[99022919]
Patient Sequence No: 1, Text Type: N, H10
[99022920]
Staff found a bad lot of disposable absorber canisters that were creating a 700-900 ml/min leak in bag mode. We removed all of the affected absorber canisters from service. No harm to patients or staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7240794 |
| MDR Report Key | 7240794 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-01 |
| Date of Event | 2017-12-07 |
| Report Date | 2018-02-01 |
| Date Reported to FDA | 2018-02-01 |
| Date Reported to Mfgr | 2018-02-01 |
| Date Added to Maude | 2018-02-05 |
| 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 | PATIENT |
| 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 | 2018-02-05 |
| Catalog Number | AMAB3801 |
| Lot Number | 24071F21 |
| 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 | KELAVESHI VC/FDA CONSULTING 7549 SPRING LAKE DR. NO. C-2 BETHESDA MD 20817 US 20817 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-05 |