RPM Respiratory Gating System 의 안전성 경고

Safety alert

2013-04-08

2013-04-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130408.html

Medical device safety alert: varian rpm respiratory gating system medical device manufacturer, varian medical systems has issued a medical device safety alert concerning real-time position management (rpm) respiratory gating systemv1.7.5 with 3d option. an anomaly has been identified with the rpm respiratory gating system software version 1.7.5, 3d option. while operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. trace inversion occurs when the breathing trace on the chart window moves in a phase opposite to the marker block movement. this event has been reported in an extremely limited number of times in the installed base, but users should be aware and monitor their displays carefully. the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-dot marker block during a calibration sequence, a reference session, or a single session after tracking has begun. in practice, this has been extremely rare. the root cause of the malfunction has been determined to lie within the smarttrack software library used only by rpm v1.7.5 with the 3d option. therefore, the manufacturer has developed a technical correction for this issue. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 april 2013.