MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-01 for SONY MONITOR PVM-2030 * manufactured by Sony Corp Of America.
[21792]
A video monitor that had been installed recently in the center had a malfunctioning vertical hold. There was potential danger to the pt because this is the only method of viewing the inside of the colon during a procedure. The screen on the video monitor is used to direct the physician during the procedure. No apparent injury occured to the pt during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010015 |
| MDR Report Key | 40400 |
| Date Received | 1996-10-01 |
| Date of Report | 1996-09-19 |
| Date of Event | 1996-09-04 |
| Date Added to Maude | 1996-10-03 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONY |
| Generic Name | VIDEO MONITOR |
| Product Code | EXZ |
| Date Received | 1996-10-01 |
| Returned To Mfg | 1996-09-13 |
| Model Number | MONITOR PVM-2030 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 41514 |
| Manufacturer | SONY CORP OF AMERICA |
| Manufacturer Address | 3 PARAGON DR MONTVALE NJ 07645 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-01 |