MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for MEDISORB M11173310 manufactured by Vyaire Medical, Inc..
[101264441]
Patient Sequence No: 1, Text Type: N, H10
[101264442]
When setting up for an operating room case, anesthesia found a crack in the plastic housing underneath the orange protective cover of a new co2 multi-absorber. The device was not use on the patient. Per manufacturer response to the hospital. (b)(4) has sold this division to vyaire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7305736 |
| MDR Report Key | 7305736 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-08 |
| Report Date | 2018-02-22 |
| Date Reported to FDA | 2018-02-22 |
| Date Reported to Mfgr | 2018-02-22 |
| Date Added to Maude | 2018-03-01 |
| 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 | MEDISORB |
| Generic Name | ABSORBENT, CARBON-DIOXIDE |
| Product Code | CBL |
| Date Received | 2018-03-01 |
| Catalog Number | M11173310 |
| Lot Number | 171104-0101 |
| Device Expiration Date | 2019-11-18 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-01 |