The reported event was confirmed.The root cause of the reported issue was due to isolated to be user related, user improperly removed the ring from the system when discharging the patient (overturning or turning in the wrong direction and pulling the ring straight off).The load cell face was completely broken off and the pins were bent, the load cell assembly was replaced.The servicing was performed as per the test procedure.The device functioning properly and was ready for use.The product would not meet the specifications, and was influenced by the reported failure.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.
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