The reported was confirmed.The root cause of the reported issue was use-related, as the user improperly removed the patient ring causing the front face of the load cell to break off.The unit was evaluated upon receipt.Load cell assembly needs to be replaced.Per evaluation, the user improperly removed the patient ring causing the front face of the load cell to break off.No repairs were made, as the customer declined repair and requested the unit be sent back without service.As a part of field action, the following components were replaced/added per the latest revision of the bill of material for sensica icu, product code sccs1001 rev h base pcba,rev c sensica icu base pcba firmware, rev d sensica icu application software, rev a windows enterprise os, rev a power supply label.Product label , usb connection label, was replaced with the latest revision of the label (rev c) per the latest bill of material for sensica icu, product code sccs1001.Replaced pcba rev h with firmware - serial number (b)(4).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "to attach the ring to the sensica uo system stand, turn the ring upside down and use a clockwise motion to twist and "lock" the ring onto the ring interface.Do not apply excessive force or torque to the ring or the system's ring interface when connecting the device to avoid damaging components.Do not turn the ring counterclockwise when attaching it." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|