Alerte De Sécurité sur InfinityR Acute Care System (IACS) Monitoring Solution with software versions VG1, VG1.2 and VG1.3

Safety alert

2011-10-13

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111013.html

Field safety notice: infinityr acute care system (iacs) monitoring solution with software versions vg1, vg1.2 and vg1.3 drager medical gmbh issued a field safety notice in october 2011 to alert healthcare providers and customers of the infinityr acute care system (iacs) monitoring solution with software versions vg1, vg1.2 and vg1.3. wrong drug dosage calculation recommendation and misalignment of ecg and art waveforms on infinity central station are possible to occur. possible wrong drug dosage calculation recommendation according to the manufacturer, the weight-based drug dosage calculation may deliver incorrect recommendation values in the iacs. the failure occurs if the patient’s body weight is not entered via the admin- / demographics screen, but entered via the drug dosage application screen. the failure occurs when entering more than one drug and will apply to the second and all further drug entries until the patient is discharged. the described behavior will not occur if the patient’s weight is correctly entered via the admin- / demographics screen. drager therefore strictly recommends their users to enter the patient’s weight in the admin- / demographics screen on the medical cockpit. possible misalignment of ecg and art waveforms on infinity central station drager has been informed about cases in germany where a misalignment of ecg and art waveforms delivered from an infinityr acute care system (iacs) monitoring solution has been observed on infinity central station. the time discrepancy between the curves observed was in the range of 5-10 seconds. drager recommends their customers to follow the instructions for use and do not consider the waveforms on infinity central station for primary diagnosis purposes. if the misalignment issue is observed, it could be cleared by undocking and redocking of the m540 or by changing the order of waveforms displayed on the cockpit screen (or any other change to the auto display screen layout). the manufacturer also mentioned that a software update will be available later to deal with the problems. according to local supplier, hong kong is affected and the affected customers will be informed. if you are in possession of the affected product, please contact your supplier immediately for necessary actions.