Initial report ref natus complaint(b)(4).Technologist was rolling the machine down the hallway and noticed an extreme tilt of the camera tower.She brought it back to the lab where they investigated the tower to figure out why it was leaning.They then observed cracks at the base of the tower.The remaining qty of equipment was examined and it was noted cracks in 6 of 7 machines purchased between (b)(6).(b)(6).Rev 69 xltek eeg psg risk analysis spreadsheet identifies hazard 6.11 - due to mechanical stress or impact, dynamic loading, vibration, or environmental conditions -- accessory shelf on cart may be unable to support the mass of accessories or items placed on its surface, causing it to bend or break and leave sharp edges exposed or broken support system could land on and harm someone.Effect (harm): range from clinically insignificant to irreversible injury resulting from direct physical injury.The hazards identified have been evaluated and found to be in compliance with a known standard.As noted in (b)(6).Hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.Install date:(b)(6).2021 pn (b)(4).-ergojust bracket kits were sent to the customer.This kit applied to the cart will stop the video extension from falling over.Field service have installed the brackets on all of the carts, all carts are now back in use.Failure confirmed: yes resolution: sending of ergojust bracket kits resolution code: preventative maintenance customer symptom code: broken/damaged part investigation case closed (b)(6).2024.
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