The rmu-1000's user manual instructs the user to apply the rmu-1000 stabilization strap once the device has begun compressions to ensure that the rmu-1000 remains appropriately positioned on the patient as improper piston position can result in injury or lack of effectiveness.In this case, based on the information received by the international distributor, the cause of the movement of the rmu-1000 from its position on the patient was determined to be related the user not applying the stabilization strap to the patient as described in the device user manual.Although in this case the patient injury was not attributed to the misuse of the device, improper positioning of the device on the patient could cause serious injury if it were to recur and hence the reason for this mdr.
|
On (b)(6) 2017, it was reported by an international distributor that the device was used on a female patient who arrived in cardiac arrest or arrested shortly after arriving to hospital, suffered a massive pulmonary embolism and died.They also reported that during the rescue the device migrated south on the patient and a post mortem of the patient identified damage to the liver and spleen; however, the doctors were unsure whether the injury was related to the device or whether the patient had been assaulted.On january 11, 2018, the international distributer reported that the medical consultant in this case, an md, agreed that there were other complications with the patient and they were not attributing her death to the use of the rmu-1000.However, they reported that although the rmu-1000's stabilization strap was provided, the customer stated that it wasn't used in this instance.
|