Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).The investigation has been done together with maquet service us as following.The end beam cover was cracked and fell off after being hit by other equipment in the room, rather than a normal use.This event occurred during the clean process by the night cleaning crew of hospital, and no patient was in the room at that time.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 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 damaged end beam cover and reminded the hospital staff to take care when positioning the device.
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