Model Number 568244710C - X10VAXL+SF |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A maquet field service technician (fst) evaluated the device and found that the metal dust cover of the light system was dislodged.Maquet assumes that the device failed to meet its specification due to an incorrect attachment of the dust cover or a detachment due to repeated collisions.Additionally, it device was directly involved with the event and was being used for treatment or diagnosis of the patient when the event occurred.The xten series installation program includes a verification of all covers of the device.
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Event Description
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The customer reported that during a surgery, the dust cover came off from the spring arm.There was no patient involved and there was no injury reported.(b)(4).
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Manufacturer Narrative
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(b)(4).A maquet field service technician replaced the metal dust cover with a new one.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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