ILED7
Received Nov 20, 2018 · Event occurred Oct 24, 2018
Report 9681407-2018-00069 · MDR key 8090346
Device
Product problems
- Mechanical Problem
- Device Tipped Over
- Unintended Movement
- Mechanical Problem
- Device Tipped Over
- Unintended Movement
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DURING INSPECTION, THE TECHNICIAN FOUND THAT THE LIGHT WAS IMPROPERLY ASSEMBLED. THE ROOT CAUSE WAS THE IMPROPER INSTALLATION OF THE STOP SCREW. THE SCREW WAS ADJUSTED AND DEVICE IS FUNCTIONING AS DESIGNED. THE MOBILE STAND VERSION HAS A HIGH TILTING STABILITY. THE FOLLOWING, BASIC PRECAUTIONS MUST BE CONSIDERED WHEN POSITIONING THE MOBILE STAND VERSION. THE STAND MIGHT TILT WHEN THE ROLLERS ARE LOCKED AND EXCESSIVE FORCE IS EXERTED ONTO THE SPRING ARM OR LIGHT HEAD. USER SHOULD AVOID STRONG LEVERAGE ONTO THE SPRING ARM OR THE LIGHT HEAD AND NOT ADD ADDITIONAL LOADS TO THE SPRING ARM.
Description of Event or Problem
DURING ARTICULATION, THE SPRING ARM ROTATED PAST ITS INTENDED STOP AND THE MOBILE LIGHT TIPPED. NO PATIENT OR CAREGIVER INJURY WAS REPORTED.
Remedial action
- Repair