Siemens became aware of an issue with the artis q ceiling system.The velcro strap that secures mattress to the patient table came off.The mattress is now insecure and can slide sideways during patient positioning.This increases risk of patients potentially falling off the table, though, we are unaware of any adverse impact to the state of health of the patients involved.
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During a service inspection, it was discovered that the velcro strip attached to the bottom of the tabletop, which is used to secure the mattress to the tabletop, had become loose.The purpose of this fixation is to prevent the movement of the mattress when there is no patient on the table and during patient transfer or positioning.However, velcro strip is not intended to prevent patient from sliding.Additional accessories, which are described in the instruction for use, must be used for this purpose.The same issue was found on a total of three different systems at the same facility.According to the information provided, the maintenance crew at the facility uses a lot of liquid during cleaning.Therefore, according to our expert opinion, the use of incorrect cleaning agents and/or large amounts of cleaning solution is the most likely cause of the velcro strips coming loose.The instruction for use contains adequate information and guidance on the use of cleaning materials.However, the issue has been discussed with the user to prevent further occurrence.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.
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