Philips IntelliVue Patient Monitors 의 리콜

Recall

RC-2016-RN-01025-1

Class II

2016-08-04

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01025-1

If an affected patient monitor has been powered on continuously for several months, any displayed waveforms will contain out-dated data and therefore fail to reflect the patient’s current condition. even if out-dated waveforms are displayed as a result of this problem, the monitor’s alarms and numeric displays of vital signs will continue to function as specified and accurately reflect current patient data. the length of time that a monitor must be powered on before the problem occurs depends on the selected wave speed. it ranges from 102 days (@50 mm/s) to 820 days (@ 6,25 mm/s), and is approximately 205 days at the monitor’s default wave speed of 25 mm/s. the monitor must be powered off in order to avoid this problem. simply placing it in stand-by mode is not sufficient. please note that connected devices, such as central monitors continue to display the correct wave data.

Philips Healthcare is advising users to cycle the power on the affected devices on a monthly basis. A software upgrade will be implemented as a permanent correction.