FDA Adverse Event
Malfunction
Summary report: N
EPIQ 7C
MDR report key: 14194114
·
Received April 25, 2022
Report
- Report Number
- 3019216-2022-00048
- Event Type
- Malfunction
- Date Received
- April 25, 2022
- Date of Event
- April 1, 2022
- Manufacturer
- PHILIPS ULTRASOUND
- Product Code
- IYN
- UDI-DI
- 00884838097872
- PMA / PMN Number
- K132304
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
RETURN OF THE SUSPECT TRANSDUCER IS ANTICIPATED. EVALUATION OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW-UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.
Additional Manufacturer Narrative · 0
EVALUATION OF THE TRANSDUCER COULD NOT CONFIRM THE ARTICULATION ISSUE AS DESCRIBED BY THE CUSTOMER. HOWEVER, THE DEVICE WAS FOUND TO BE DAMAGED. VISUAL INSPECTION NOTED, PAINT CHIPS ON CONNECTOR, SCRATCHES ON MID-HANDLE, PROTEIN BUILD-UP ON I- TUBE, SCRATCHES ON I-TUBE AND SCRATCHES ON TIP SHELL.
Description of Event or Problem · 0
A CUSTOMER REPORTED AN X8-2T TRANSDUCER WOULD NOT ARTICULATE ON AN EPIQ 7C ULTRASOUND SYSTEM DURING USE. A NEW TRANSDUCER HAS BEEN ORDERED TO REPLACE THE SUSPECT TRANSDUCER TO RESOLVE THIS ISSUE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170616 | EPIQ 7C | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | IYN | PHILIPS ULTRASOUND | EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM | 00884838097872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |