Puritan Bennett 840 Ventilator 의 안전성 경고

Safety alert

2014-06-10

2014-06-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140609.html

Medical device safety alert: covidien puritan bennett 840 ventilator the australia therapeutic goods administration (tga) posted a medical device safety alert concerning puritan bennett 840 ventilator manufactured by covidien. the affected ventilator serial numbers are 3510102854, 3510102868, 3510102839, 3510102853, 3510102849, 3510102848 and 3510102852, and the serial numbers of the affected power supply units are 39302, 40221, 40355, 40465, 40324, 40327 and 40450. the manufacturer has received customer reports of the loss of graphical user interface (gui) display information while the ventilator continues to provide breath support. customer reports describe the gui display screens (both upper and lower) becoming blank during patient use. this event interferes with the clinician's ability to view and/or change ventilator setting or clinician-set patient alarm parameters. loss of gui display due to a power supply unit (psu) failure is demonstrated by the ventilator entering a “gui inop” state i.E. if the breath delivery unit (bdu) loses communication with the gui, the bdu recognises this and enters a “gui inop” state. it initiates the appropriate alarm consisting of a visible alarm indicated by the illumination of the “gui inop” red light on the bdu and a high-priority audible alarm. the source of the psu voltage loss is a specific circuit responsible solely for the gui central processing unit voltages. a representative from the manufacturer will perform an inspection of affected ventilator(s) to determine if it has the affected component and if so, will replace the psu immediately. if users encounter a loss of display, they are advised to verify the patient’s respiratory and physiological stability i.E. confirm the patient is receiving ventilatory support by observation of the expansion and contraction of the patient’s chest and assess current patient status by review of other monitoring parameters (e.G., oxygen saturation, heart rate, blood pressure, etc). also, the manufacturer advises users to promptly transfer the patient to an alternate ventilator in a manner consistent with the institutional protocol and remove the affected ventilator from use until it has been serviced. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00618-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 june 2014.