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 2020-01-10 for VIEWMATE? Z ULTRASOUND CONSOLE WBATTERY ZS3 H701336 manufactured by Zonare Medical Systems, Inc.
[174702810]
The results, method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[174702811]
During a procedure, when the viewmate system was started, the console keys were not working as the patient information could not be entered. When the catheter was connected, it would not register. The system was power cycled, the probes were replaced, and the battery was re-inserted, but the issue remained. The procedure was ultimately continued by switching to tee imaging, but this transition required increased sedation time for the patient. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004189859-2020-00001 |
| MDR Report Key | 9577319 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-21 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2015-12-22 |
| Date Added to Maude | 2020-01-10 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ZONARE MEDICAL SYSTEMS, INC |
| Manufacturer Street | 420 NORTH BERNARDO AVENUE |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIEWMATE? Z ULTRASOUND CONSOLE WBATTERY ZS3 |
| Generic Name | SYSTEM, SIGNAL ISOLATION |
| Product Code | DRJ |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-01-06 |
| Model Number | H701336 |
| Catalog Number | H701336 |
| Lot Number | 5333597 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZONARE MEDICAL SYSTEMS, INC |
| Manufacturer Address | 420 NORTH BERNARDO AVENUE MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-10 |