Esprit V1000 and Esprit/V200 Conversion Ventilators 의 안전성 경고

Safety alert

2014-11-21

2014-11-21

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141121.html

Medical device safety alert: respironics esprit v1000 and esprit/v200 conversion ventilators medical device manufacturer, respironics california, inc., a division of philips healthcare, has issued a field safety notice concerning its esprit v1000 and esprit/v200 conversion ventilators. the affected serial numbers are vs3005856, vs3006203, vs3002006 and vs3002033. according to the manufacturer, if the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (pcba) and short to ground which may prevent the ventilator to switch to battery power if ac power is disrupted. a high urgency audible alarm will sound alerting medical personnel of the loss of power. in the absence of ac power, failure of battery power will cause loss of ventilator support which could result in hypercarbia or hypoxemia. the manufacturer would install new fan installation hardware kits on affected units. the manufacturer advises that pending the completion of the fan mounting hardware update, the esprit v1000 & esprit/v200 conversion ventilators may continue to be used in accordance with the directions for use. the manufacturer also advises users of the followings:- it is recommended that the power fail alarm test in appendix c of the operator’s manual be followed prior to clinical use of the ventilator. the ventilator will provide audio and visual indication when it is operating on backup battery. whenever the ventilator is powered by backup battery, it will generate a non-resettable, non-silenceable alarm that creates an alarm sound every 60 seconds. during battery operation the yellow front panel indicator labeled battery in use on the top left hand side of the ventilator will be on continuously. if ac power is disrupted and the ventilator cannot switch to battery operation, a high urgency alarm will sound and the patient must be supported with another means of life support ventilation. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 november 2014.