MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for MEDISORB M1173311 manufactured by Vyaire Medical Oy.
[184156482]
Product defect discovered during anesthesia pre-check. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093730 |
| MDR Report Key | 9829048 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-10 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDISORB |
| Generic Name | ABSORBER CARBON-DIOXIDE |
| Product Code | BSF |
| Date Received | 2020-03-12 |
| Model Number | M1173311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL OY |
| Manufacturer Address | HELSINKI, FN FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |