FDA Adverse Event
Malfunction
Summary report: N
TRANSDUCER S8-3T MICRO TEE
MDR report key: 3748072
·
Received January 24, 2014
Report
- Report Number
- 3019216-2014-00002
- Event Type
- Malfunction
- Date Received
- January 24, 2014
- Report Date
- December 27, 2013
- Manufacturer
- PHILIPS ULTRASOUND, INC.
- Product Code
- IYO
- PMA / PMN Number
- K030455
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION OF THE RETURNED TRANSDUCER CONFIRMED POOR IMAGE QUALITY. THE ROOT CAUSE WAS DETERMINED TO BE A TINY PINHOLE IN AN INTERNAL COMPONENT. THE SUPPLIER IS TAKING CORRECTIVE/PREVENTATIVE ACTION TO ADDRESS THIS ISSUE. THERE HAVE BEEN NO ADVERSE EVENTS AS A RESULT OF THIS ISSUE. ADDITIONAL 510(K)#: K034003.
Description of Event or Problem · 1
PHILIPS HEALTHCARE CUSTOMER SERVICE CENTER RECEIVED A CALL FROM THE CUSTOMER STATING THAT THEIR S8-3T TRANSDUCER WAS GIVING POOR IMAGE QUALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56075 | TRANSDUCER S8-3T MICRO TEE | IYO IYN ITX | IYO | PHILIPS ULTRASOUND, INC. | 989605379471 | B0KV8J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |