FDA Adverse Event
Malfunction
Summary report: N
VIVID E9
MDR report key: 4322335
·
Received December 3, 2014
Report
- Report Number
- 4322335
- Event Type
- Malfunction
- Date Received
- December 3, 2014
- Date of Event
- December 2, 2014
- Report Date
- December 3, 2014
- Manufacturer
- GENERAL ELECTRIC CO.
- Product Code
- IYO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
ULTRASOUND UNIT SHUTDOWN DURING TEE PROCEDURE IN CATH LAB WOULD NOT TURN BACK ON HAD TO BRING IN SECOND UNIT. THERE WAS A 10-15 MIN DELAY WITH TEE STILL IN PATIENT REQUIRING MORE SEDATION.THIS FACILITY HAS HAD SEVERAL SIMILAR EVENTS WITH THIS DEVICE. THE MANUFACTURER HAS BEEN NOTIFIED AND SENDS A REP TO INSPECT/REPAIR THE DEVICE. THE MANUFACTURER WILL NOT REPLACE THE DEVICE. THE CAUSE OF THE PROBLEM IS UNKNOWN AND HAS NOT BEEN ABLE TO BE PREVENTED.======================MANUFACTURER RESPONSE FOR ULTRASOUND UNIT, VIVID E9 (PER SITE REPORTER).======================THE UNIT IN QUESTION HAS FAILED NUMEROUS TIMES SERVICE TECH IN TO FIX KEEPS ON FAILING GE WILL NOT REPLACE CAUSING PATIENT SAFETY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779449 | VIVID E9 | ULTRASOUND UNIT | IYO | GENERAL ELECTRIC CO. | VIVID E9 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |