D
Patient 1
DURING THE PROCEDURE, AFTER THE PATIENT WAS PREPPED, INCORRECT VIDEO WAS DISPLAYED. THE ISSUE WAS NOT RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
MAUDE MDR 6929449
- MDR report key
- 6929449
- Report number
- 2184149-2017-00031
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-09-15
- Date received
- 2017-10-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DENISE JOHNSON
- Address
- 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US
- Phone
- 651-651-6517
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VANTAGEVIEW? SYSTEM | MEDICAL CATHODE-RAY TUBE DISPLAY | ST. JUDE MEDICAL, INC. | DXJ | VS100003 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-09 | 0 | 1. O |
Event Narratives#
N
Patient 1
BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE INCORRECT DISPLAY ASPECT RATIO WAS ISOLATED TO FAULTY INTERNAL COMPONENTS RESULTING IN ABNORMAL FUNCTION OF THE RETURNED VIDEO CONVERTER MODULE. THE SYSTEM MET SPECIFICATIONS AND REQUIREMENTS PRIOR TO RELEASE FROM THE VENDOR AND MANUFACTURING FACILITIES AS SUPPORTED BY THE SYSTEM INSTALLATION REPORT.