FDA Adverse Event
Malfunction
Summary report: N
SEDECAL, MADE FOR: PHILIPS
MDR report key: 3268068
·
Received July 22, 2013
Report
- Report Number
- 9617251-2013-00002
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Date of Event
- March 12, 2013
- Report Date
- July 18, 2013
- Manufacturer
- SEDECAL S.A.
- Product Code
- IZL
- PMA / PMN Number
- K111725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ROOT CAUSE OF THIS EVENT IS A DEFECTIVE STRAIN GAUGE IN THE MOTION CONTROL ELECTRONICS.
Description of Event or Problem · 1
"THERE WAS NO INJURY. THIS IS A MOBILE X-RAY SYSTEM. WHILE TRYING TO MOVE THE SYSTEM UNDER MOTORIZED CONTROL, THE UNIT TURNED WITHOUT BEING COMMANDED TO DO SO AND HIT THE WALL. A SERVICE TECHNICIAN CHECKED THE SYSTEM AND FOUND A DEFECTIVE MOTOR STRAIN GAUGE. THE SYSTEM WAS REPAIRED AND NOW PERFORMS NORMALLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339842 | SEDECAL, MADE FOR: PHILIPS | MOBILE X-RAY | IZL | SEDECAL S.A. | MOBILEDIAGNOST WDR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |