MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for MEDISORB REF: M1173310 manufactured by Vyaire Medical, Inc..
[119662215]
Hard plastic soda lime absorb canisters are easily cracked during handling causing high pressure leaks in the anesthesia ventilator system. The cracks are usually small and hard to locate by visual inspection. When compared to the old soda lime absorbers used at our facility - these current co2 absorbers are more susceptible to breaks and cracks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7859513 |
| MDR Report Key | 7859513 |
| Date Received | 2018-09-10 |
| Date of Report | 2018-08-23 |
| Date of Event | 2016-01-29 |
| Report Date | 2018-08-23 |
| Date Reported to FDA | 2018-08-23 |
| Date Reported to Mfgr | 2018-09-10 |
| Date Added to Maude | 2018-09-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BSF |
| Date Received | 2018-09-10 |
| Model Number | REF: M1173310 |
| Catalog Number | REF: M1173310 |
| Lot Number | 180404-0038 |
| Device Availability | N |
| Device Age | 1 DA |
| 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 | 2018-09-10 |