MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for PORTEX SODASORB CO2 ABSORBENT 008870 manufactured by Smiths Medical Asd, Inc..
[141751228]
Information was received that a smiths medical portex sodasorb co2 absorbent was broken, which generated an "error" alarm on the machine. Event occured prior to use with a patient. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-01905 |
| MDR Report Key | 8499876 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-10 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, KENT |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTEX SODASORB CO2 ABSORBENT |
| Generic Name | ABSORBER, CARBON-DIOXIDE PRODUCT CODE: BSF |
| Product Code | BSF |
| Date Received | 2019-04-10 |
| Returned To Mfg | 2019-04-08 |
| Catalog Number | 008870 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |