This complaint has been evaluated based on the information provided.The customer reported that after a patient scanning was completed, the patient couch suddenly dropped while lowering the couch.Philips field service engineer(fse) inspected system and identified that ball bearing and ball screw were defective.Fse had the new ball bearing service kit installed and returned the system to customer for clinical use.Patient was frightened but was not actually harmed.A similar product regarding couch dropping downwards rapidly was recently assessed as potential for serious injury if it were to recur.Based on that assessment, we are considering this event reportable out of abundance of caution.Philips has started an investigation of this complaint.
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The customer, people's hospital of hezhang county, bijie city, guizhou province, reported that after a patient scanning was completed, the patient couch suddenly dropped while lowering the couch.The system was in clinical use during the event.A philips field service engineer (fse) went onsite to evaluate the reported issue and confirmed the patient was not injured and did not receive any treatment.A system inspection determined that the vertical screw rod of the patient couch was not damaged, the cause of the failure was the long-term wear of the bearing.Fse replaced the bearings service kit, and the system was returned to use in good working order.In conclusion, a ball bearing failure was the root cause of the event.A review of the risk management file indicates the problem reported by the customer is of low potential severity, which would not reasonably cause or contribute to death or serious injury if the problem were to reoccur.Therefore, based on the investigation¿s conclusion, this issue has been determined not to be a reportable event.
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