The investigation has been done together with maquet service us as following.- customer stated that the end beam cover fell off after being hit by other equipment in the room , rather than a normal use.As checked, this unit was manufactured and delivered in year 2015, and there was no any feedback regarding the end beam cover connection during installation or previous maintenance.Therefore, we could believe it¿s in a normal condition as intended until this issue happened.- the design of the end beam cover is demonstrated compliance with (b)(4) by design verification, and additionally a warning is included in user manual to remind the customer to avoid collision when moving devices.Therefore, the design of the end beam cover was demonstrated robust for normal use.With the above information, we can indicate this complaint case is caused by use error- careless during positioning of the device which resulting in the hitting between devices.Maquet service us had replaced the broken end beam cover, adjusted the stops on the modutec and instructed the customer on the proper use of the modutec to help avoid collisions.
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On jun 08, 2017, the hospital staff told maquet service us that the beam end cover of the modutec fell off after being hit, and the exact event date was unknown.No injury was reported.(b)(4).
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