A philips customer service clinical representative spoke with the customer.According to the audit log, multiple alarms for low sp02 and multiple alarms for low battery and then sp02 t off and then replace battery were sounded and acknowledged at the philips intellivue information center ix (piic ix) surveillance station.Then another notification that the device itself was off was found in the log.Per the ifu, spo2 measurement turns off when the inop appears and the display cannot be turned on once thetele batt low inop starts.If the screen was already on (device in monitoring mode or off network) then the screen dims when the battery is low.Per the telemetry service guide, telemetry battery safety warnings indicate "if you receive a tele battery low, tele battery empty, replace battery t, or tele battery temp alarm, the batteries must be promptly replaced.If these conditions are not corrected, they will result in a device shutdown and cessation of monitoring." the investigation indicates that the device was operating as expected.The investigation did not confirm a product malfunction.Good faith efforts were made to obtain additional information regarding whether the customer is alleging that the device contributed to the patient death, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.No further investigation or action is warranted at this time.
|
Updated 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.
|