FDA Adverse Event
Other
Summary report: N
IE 33 ULTRASOUND SYSTEM
MDR report key: 2477512
·
Received February 9, 2012
Report
- Report Number
- 3019216-2012-00002
- Event Type
- Other
- Date Received
- February 9, 2012
- Report Date
- January 12, 2012
- Manufacturer
- PHILIPS ULTRASOUND, INC
- Product Code
- IYO
- PMA / PMN Number
- K030455
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. AT THE TIME OF THIS REPORT, THERE IS NO EVIDENCE TO INDICATE THAT THE ULTRASOUND SYSTEM MALFUNCTIONED.
Description of Event or Problem · 1
CUSTOMER REPORTED: "PT UNDERWENT PREOPERATIVE TEE WITH ECHOCARDIOGRAM MATRIX PROBE ON (B)(6) 2011 TRANSTHORACIC ECHOCARDIOGRAM IMAGES, THE PT WENT TO THE OPERATING ROOM ON (B)(6) 2012 AND CARDIAC SURGERY WAS NOT PERFORMED SINCE THE TEE IDENTIFIED MITRAL REGURGITATION.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IE 33 ULTRASOUND SYSTEM | IYO, IYN, ITX | IYO | PHILIPS ULTRASOUND, INC | 795052 | B06BNC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Other |