MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-21 for SODASORB 504 REV 1 manufactured by Wr Grace & Co..
[843907]
High vent pressures were noted on anesthesia gas machine. Pt ws checked. Clinical engineering called. Anesthesia gas machine checked after no issue found with patient. Upon investigation of gas machine, the pre-pack sodasorb was noted to not have the appropriate vented perforation on the bottom. Thus, not allowing proper flow creating the increase pressures. Sodasorb canister changed - pt status unchanged. Peak pressures normal. Could have caused barotrauma or other injury. Dates of use: (b)(6) 2008. Diagnosis or reason for use: part of anesthesia machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006339 |
| MDR Report Key | 1032543 |
| Date Received | 2008-04-21 |
| Date of Report | 2008-04-15 |
| Date of Event | 2008-04-14 |
| Date Added to Maude | 2008-04-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SODASORB |
| Generic Name | NONE |
| Product Code | CBL |
| Date Received | 2008-04-21 |
| Model Number | 504 REV 1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1000888 |
| Manufacturer | WR GRACE & CO. |
| Manufacturer Address | 6050 WEST 51ST CHICAGO IL 60638 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-21 |