MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-11 for BLADDERSCAN BVI9400 NA manufactured by Verathon.
[1291447]
The device simply locked up and would not work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645776 |
| MDR Report Key | 1645776 |
| Date Received | 2010-03-11 |
| Date of Report | 2010-03-11 |
| Date of Event | 2010-02-25 |
| Report Date | 2010-03-11 |
| Date Reported to FDA | 2010-03-11 |
| Date Added to Maude | 2010-03-30 |
| 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 | 0 |
| 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 | BLADDERSCAN |
| Generic Name | BLADDER SCANNER |
| Product Code | EXQ |
| Date Received | 2010-03-11 |
| Model Number | BVI9400 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON |
| Manufacturer Address | 20001 NORTH CREEK PARKWAY BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-11 |