G4:22apr2021.B4:26apr2021.H11: there was no patient involvement when the issue was discovered.H10: the device was evaluated by the customer with assistance from a philips remote service engineer (rse) and it was determined that the touchscreen needed to be replaced to return the device to working condition.The customer¿s biomed replaced the touchscreen to resolve the issue and bring the device back to functionality.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.
|