MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-22 for MED X CHANGE DRSHD-L -HIGH DEFINITION DIGITAL RECORDING SYST MEDXCHANGER * manufactured by Conmed Linvatec.
[5020199]
Video scanner did not print images of case it was supposed to. Unable to print at all and unknown what caused device not to print. ======================manufacturer response for video scanner - printer, medxchanger (per site reporter). ======================sales representative told us how to retrieve the pictures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4168993 |
| MDR Report Key | 4168993 |
| Date Received | 2014-09-22 |
| Date of Report | 2014-09-22 |
| Date of Event | 2014-09-08 |
| Report Date | 2014-09-22 |
| Date Reported to FDA | 2014-09-22 |
| Date Reported to Mfgr | 2014-10-14 |
| Date Added to Maude | 2014-10-14 |
| 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 | MED X CHANGE DRSHD-L -HIGH DEFINITION DIGITAL RECORDING SYST |
| Generic Name | DEVICE, DIGITAL IMAGE STORAGE |
| Product Code | LMB |
| Date Received | 2014-09-22 |
| Model Number | MEDXCHANGER |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-22 |