FDA Adverse Event
Malfunction
Summary report: N
PHILIPS EPIQ 7C DIAGNOSTIC ULTRASOUND SYSTEM
MDR report key: 16940512
·
Received May 15, 2023
Report
- Report Number
- MW5117552
- Event Type
- Malfunction
- Date Received
- May 15, 2023
- Date of Event
- May 9, 2023
- Report Date
- May 10, 2023
- Manufacturer
- PHILIPS ULTRASOUND LLC
- Product Code
- IYO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PHILIPS EPIQ 7C ULTRASOUND UNIT BEGAN SMOKING. UNIT WAS REMOVED FROM THE FACILITY WHERE IS WAS SPRAYED WITH A FIRE EXTINGUISHER. THE FIRE DEPARTMENT THEN REPORTED TO THE SCENE WHERE THEY DOUSED THE UNIT WITH WATER. THEY THEN REMOVED THE LIION BATTERY AND COVERED IT WITH CHEMICAL FOR LITHIUM ION BATTERIES AND THEN SOAKED THE BATTER IN WATER. THE RESULTED IN COMPLETE LOSS OF THE U/S UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817929 | PHILIPS EPIQ 7C DIAGNOSTIC ULTRASOUND SYSTEM | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | IYO | PHILIPS ULTRASOUND LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |