It was reported to arjo that a patient cut his toe on a damaged auto logic hanging brackets (bed hook).The patient was being treated by a podiatrist.The hanging bracket allows attaching the auto logic pump to the bed frame and consists of metal rod covered by the pvc coating.Allegedly, the pvc coating came loose exposing the metal rod.It is unknown in which circumstances the pvc coating on the pump hanging bracket could be damaged.Despite attempts to localize the pump and verify the customer's allegation, the pump could not be located.The quality check of the pump, which was performed after the device returned from rental, did not show any anomalies, the product passed the requirements.Additionally there was no service records related to the hooks replacement before the event and even after the event on 1 september, a repair that was performed on this pump had not hook included, but only the rear and front casing.This allowed us to conclude that the customer's allegation cannot be verified considering all the evidence provided.The auto logic service manual (b)(4) dated 11/2019 in section pump maintenance checks states to check the hooks for damage."if any parts are found to be damaged they must be replaced".We are unable to verify the customer's allegation related to metal part exposing, neither we can indicate the cause of the alleged pvc coating missing.A review of complaints related to the sharp edges from the hanging bracket used on autologic pump allowed to established that this complaint is a singular event.The arjo device was used for a patient¿s treatment when the event occurred and therefore played a role in the reported issue.No failure could be identified in the pump, that would explain the customer allegation.The complaint was decided to be reportable due to the serious outcome to the user.
|