MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for FALCON FALCON PRO manufactured by Viasonix.
[90456995]
Patient Sequence No: 1, Text Type: N, H10
[90456996]
The particle board panel where the lcd monitor sits on suddenly became dislodged from the back side and therefore tilted forward. The sonographer was almost hit by the lcd monitor. Per reporter, the manufacturer has been very receptive. The manufacturer representative was notified that the hospital remediated the problem with a better solution and returned the unit to service. The representative requested pictures which showed the system prior and after remediation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6983114 |
| MDR Report Key | 6983114 |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-08-29 |
| Report Date | 2017-08-31 |
| Date Reported to FDA | 2017-08-31 |
| Date Reported to Mfgr | 2017-08-31 |
| Date Added to Maude | 2017-10-27 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FALCON |
| Generic Name | MONITOR, PERIPHERAL |
| Product Code | JOP |
| Date Received | 2017-10-27 |
| Model Number | FALCON PRO |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VIASONIX |
| Manufacturer Address | JOHN HAEFELE 125 COMMERCE PARK RD N KINGSTOWN RI 02852 US 02852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-27 |