MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-09 for VANTAGEVIEW? SYSTEM VS100003 manufactured by St. Jude Medical, Inc..
[89503978]
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.
Patient Sequence No: 1, Text Type: D, B5
[117876399]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2017-00031 |
| MDR Report Key | 6929449 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-09 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2014-01-30 |
| Date Added to Maude | 2017-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANTAGEVIEW? SYSTEM |
| Generic Name | MEDICAL CATHODE-RAY TUBE DISPLAY |
| Product Code | DXJ |
| Date Received | 2017-10-09 |
| Returned To Mfg | 2017-11-10 |
| Model Number | VS100003 |
| ID Number | 05415067010841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-09 |