Medivators field service engineer discovered while repairing their aer unit that the facility had made multiple modifications and adjustments to the internal system such that the device is out of specification.This includes filter housing and hookup connector modifications.Upon further inspection of the unit and extent of the repairs needed, it was reported that the facility was not doing the necessary maintenance in accordance with the ifu.In the fse report, it stated that multiple machine components were broken, leaking, or even missing.This could potentially lead to improper reprocessing of endoscopes, thus potential for patient harm.This facility does not have a service agreement with medivators, so records indicate that medivators field personnel has not visited this facility since installation.No patient illness or injury has been reported to medivators.This complaint will continue to be maintained within medivators complaint handling system.
|