MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-17 for VENTSCAN IV DISPOSABLE 177-092 * manufactured by Biodex.
[2848307]
Technician reported the vent kit failed to nebulize properly during pre-exam test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2689202 |
| MDR Report Key | 2689202 |
| Date Received | 2012-07-17 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-06-26 |
| Report Date | 2012-07-17 |
| Date Reported to FDA | 2012-07-17 |
| Date Added to Maude | 2012-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTSCAN IV DISPOSABLE |
| Generic Name | SYSTEM, REBREATHING, NEBULIZER |
| Product Code | IYT |
| Date Received | 2012-07-17 |
| Model Number | 177-092 |
| Catalog Number | * |
| Lot Number | 411516 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODEX |
| Manufacturer Address | 20 RAMSAY ROAD SHIRLEY NY 11967470 US 11967 4704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-17 |