intellivue patient monitors and avalon fetal monitors 의 안전성 경고

Safety alert

2014-10-15

2014-10-15

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141015.html

Medical device safety alert: philips intellivue patient monitors and avalon fetal monitors medical device manufacturer, philips, has issued a field safety notice (fsn) concerning: intellivue patient monitors with software revisions j.21.03 and j.21.19; and model (product) numbers of mp5 (m8105a), mp5sc (m8105as), mp5t (m8105at), and mp5 upgrades (m8105au, 866327) avalon fetal monitors with software revision j.30.58; and model (product) numbers of fm20 (m2702a), fm30 (m2703a) and fm50 (m2705a) in time-synchronized automatic/sequence mode the non-invasive blood pressure (nbp) automatic measurement series is stopped inadvertently, if the repetition interval is increased manually by the user (e.G. from 5 to 15 minutes) in between two consecutive measurements. a prompt message “any ongoing nbp measurement and automatic cycle stopped” is displayed and a single tone sounds when the measurement series is stopped. after the automated measurement series has been stopped, nbp numeric, repetition time, and time to next measurement are no longer displayed, i.E. the nbp numeric field is blank. if the nbp measurement is stopped, and a patient’s blood pressure is not being monitored, a delay in treatment could occur. customers with affected devices will be contacted to arrange a software upgrade to correct the issues. during the interim period until the software is upgraded, users should make sure, if the nbp repetition interval needs to be increased (e.G. from 5 to 15 minutes), to restart the automatic nbp measurement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 15 october 2014.