FDA Adverse Event
Malfunction
Summary report: N
SYNAPSE PACS
MDR report key: 17607600
·
Received August 23, 2023
Report
- Report Number
- 3004972322-2023-00002
- Event Type
- Malfunction
- Date Received
- August 23, 2023
- Date of Event
- July 24, 2023
- Manufacturer
- FUJIFILM HEALTHCARE AMERICAS CORPORATION
- Product Code
- LLZ
- UDI-DI
- 00854904006008
- PMA / PMN Number
- K160108
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF A PRODUCT PROBLEM INVOLVING SYNAPSE PACS V7.3. IT WAS REPORTED THAT THERE IS AN INCORRECT EQUATION FOR LV MASS (2D BULLET) CALCULATION. THE FORMULA THAT EQUATES THE MASS OF THE LEFT VENTRICLE IS INCORRECTLY CALCULATING THE LV WALL THICKNESS CAUSING THE DIFFERENCE TO VARY DEPENDING ON THE AMOUNT OF THICKNESS THAT EXISTS IN THE VENTRICLE. THICKER LV WALLS WILL CAUSE A LARGER DIFFERENCE IN THE RESULTS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1482951 | SYNAPSE PACS | PICTURE ARCHIVING AND COMMUNICATION SYSTEM | LLZ | FUJIFILM HEALTHCARE AMERICAS CORPORATION | N/A | N/A | 00854904006008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |