The customer confirmed that the patient was not harmed as a result of the issue.A backup ultrasound system was used to successfully complete the examination.Evaluation of the x7-2t model transducer identified damage to the cable and performance testing revealed a failed image test resulting in an error message.The evaluation also concluded the issue observed in the field was caused by the damaged cable.This cable was replaced to repair the device to full functionality.The exact cause of the damage could not be determined, however, philips concludes that this is not a manufacturing or design based defect and is indicative of improper maintenance.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|