MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for AMSORB PLUS AMAB3801 manufactured by Vc/fda Consulting.
[185711625]
During room turnover anesthesia gas machine did not pass leak test. After in-servicing bio-med was called. It was noted by bio-med rep that the engineering on the amsorb plus product is off by 1mm on the ge machine which was causing a small leak to be detected. After researching we noted that some machines will pick up the leak and some will not due to the minute offsetting. Our concern was if this was transpiring in other facilities but has not been reported due to it being caught before patient is attached to machine or anesthesia tech not realizing it is an engineering malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902766 |
| MDR Report Key | 9902766 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-11 |
| Report Date | 2020-03-19 |
| Date Reported to FDA | 2020-03-19 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-31 |
| Model Number | AMAB3801 |
| Catalog Number | AMAB3801 |
| Lot Number | 210619F31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VC/FDA CONSULTING |
| Manufacturer Address | 7549 SPRING LAKE DR. NO. C-2 BETHESDA MD 20817 US 20817 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |