MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-25 for AMSORB AMAB4001 manufactured by Armstrong Medical Ltd..
[23947904]
Patient Sequence No: 1, Text Type: N, H10
[23947905]
Complete system leak - unable to ventilate patient. Noticed co2 absorber loose and changed the canister. The co2 absorbent on "trial" was cracked or broken on top. This caused a leak in the anesthesia machine and we were unable to ventilate the patient. Able to ventilate after changing the canister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5027399 |
| MDR Report Key | 5027399 |
| Date Received | 2015-08-25 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-07-07 |
| Report Date | 2015-07-14 |
| Date Reported to FDA | 2015-07-14 |
| Date Reported to Mfgr | 2015-07-14 |
| Date Added to Maude | 2015-08-25 |
| 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 |
| 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 |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2015-08-25 |
| Model Number | AMAB4001 |
| Lot Number | 090215F41 |
| Device Expiration Date | 2018-01-31 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2015-08-25 |