FDA Adverse Event
Malfunction
Summary report: N
SONOSITE PLUS HAND-CARRIED ULTRASOUND SYS
MDR report key: 403769
·
Received July 3, 2002
Report
- Report Number
- 3032367-2002-00001
- Event Type
- Malfunction
- Date Received
- July 3, 2002
- Date of Event
- May 31, 2002
- Report Date
- July 3, 2002
- Manufacturer
- SONOSITE, INC.
- Product Code
- IYO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE USER FACILITY HAD A SYSTEM WHICH FAILED AND MELTED A HOLE THROUGH THE PLASTIC ENCLOSURE OF THE SYSTEM WHILE IN A SITESTAND. ACCORDING TO THE COMPANY'S DISTRIBUTOR IN CANADA, THERE IS A DIME-SIZE BURN HOLE ON THE BACK OF THE SYSTEM NEAR THE FAN. THE CUSTOMER WAS NOT USING THE SYSTEM AT THE TIME AND NO ACTUAL FLAMES WERE OBSERVED. THE CUSTOMER COULD TELL THERE WAS A PROBLEM BECAUSE OF THE SMELL OF BURNED PLASTIC. THE SYSTEM AND STAND ARE P01576-04, P01606-02.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONOSITE PLUS HAND-CARRIED ULTRASOUND SYS | SONOSITE 180PLUS | IYO | SONOSITE, INC. | P01576-04 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |