G4: 02feb2020 b4: (b)(6) 2020 h11:b1:h1: updated: the device was in use on a patient when the reported problem occurred.Undisclosed patient incident.G4: 15jul2020 b4: (b)(6) 2020 the device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer is reported that the unit failed the pressure accuracy testing.The customer installed a new data acquisition board, a new v60 battery, completed the v60 performance verification, and the device has been returned to service.No relevant medical history, relevant past drug history, relevant concomitant medical products, or relevant laboratory data was reported.Limited information was provided for this safety report.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|