MOUNT

Description of Event or Problem

THIS LETTER IS TO INFORM YOU THAT GE HEALTHCARE (GEHC) RECEIVED A COMPLAINT FROM (B)(6) REPORTING THAT A NURSE SUSTAINED A SHOULDER INJURY WHILE ATTEMPTING TO CATCH A FALLING GE HEALTHCARE (GEHC) PATIENT MONITOR. THE CUSTOMER COULD NOT PROVIDE ANY FURTHER DETAILS PERTAINING TO THE EXTENT OF THE NURSE¿S INJURY AND ANY TREATMENT THAT MAY HAVE BEEN REQUIRED. THE CUSTOMER SUBSEQUENTLY DETERMINED THAT THE GCX MOUNT HAD FAILED THUS CAUSING THE GEHC MONITOR TO FALL. THE GCX MOUNT IS NOT MANUFACTURED BY GEHC. THE MOUNT IS MANUFACTURED BY GCX MOUNTING SOLUTIONS, WHO¿S AMERICAN OPERATIONS ARE IN (B)(6). GEHC NOTIFIED GCX MOUNTING SOLUTIONS OF THE EVENT ON (B)(6) 2023. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).