MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for SODASORB 008870 manufactured by Smiths Medical Asd, Inc..
[96842575]
Patient Sequence No: 1, Text Type: N, H10
[96842576]
The design of the product allows for the product to be placed in the anesthesia machine (mindray) upside down and once the absorbent is exhausted and wet the canister cannot be released from the holder. The upper circumference of the canister is marginally larger than the bottom; however there is no notation on the supply to indicate how the canister should be placed in the holder i. E. This end up, etc. One patient's etc02 reached 70 and required manual ventilation while the canister was removed from the holder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7178130 |
| MDR Report Key | 7178130 |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-12-14 |
| Report Date | 2017-12-20 |
| Date Reported to FDA | 2017-12-20 |
| Date Reported to Mfgr | 2017-12-20 |
| Date Added to Maude | 2018-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SODASORB |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2018-01-10 |
| Model Number | 008870 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 1265 GREY FOX RD SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |