Model Number 4028210 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that a iled 3 surgical light fell down as the spring arm separated from the support arm system.The falling component hit a person at the shoulder and the knee.The person is currently on sick leave.No details of the injury , results of x-ray and medical examination were not provided by the customer so far.This report was filed in our complaint handling system as complaint # (b)(4).
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Manufacturer Narrative
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The iled 3 was inspected by a field service technician.Further investigation is ongoing.
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Manufacturer Narrative
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The iled light system was inspected by a field service technician.It was identified the snap ring which holds the spring arm in place dislodged and allowed the spring arm to separate from the central axis.Significant signs of wear was visible at the spring arm - central axis connection.Within the device history the last preventive maintenance is recorded for 2018.During the required preventive maintenance the snap ring has to be inspected for correct fit and function.The preventive maintenance is required for each year at this device age.The light system involved in the event passed it's intended design life of ten years.The root cause for the event was traced to not following the instructions for use, missing regularly preventive maintenance.The light system was repaired and checked for functionality.Based on this, no further actions are required.
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Event Description
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It was reported that a iled 3 surgical light fell down as the spring arm separated from the support arm system.The falling component hit a person at the shoulder and the knee.The person is currently on sick leave.No details of the injury, results of x-ray and medical examination were not provided by the customer so far.This report was filed in our complaint handling system as complaint # (b)(4).
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Search Alerts/Recalls
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