BVM (Bag-Valve-Mask) Manual Resuscitation Systems 의 안전성 경고

Safety alert

2018-01-09

2018-01-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180109a.html

Medical device safety alert: intersurgical ltd bvm (bag-valve-mask) manual resuscitation systems the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning bvm (bag-valve-mask) manual resuscitation systems, manufactured by intersurgical ltd. the affected devices are identified as the following:- reference numbers (lot numbers): 7150000 (363791, 370252, 370751, 371638, 372887, 372894, 375508) 7151000 (364909, 370253, 371091, 371639, 372886, 372890, 375711) 7152000 (363792, 364270, 364923, 365216, 370266, 370752, 371640, 371656, 372888, 372889, 372893, 373638, 373639, 375411) 7152005 (31753284, 31756956, 31757575) 7152006 (31660106, 31753127, 31756716, 31757576, 31758289) 7152007 (371092) 7152012 (31753733, 31756957) 7153000 (363793, 370738, 371907, 372892, 375509) 7153008 (31753734) 7154000 (370753, 372367) a manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the ‘back plate’ of the self-inflating bag being orientated incorrectly. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma. according to the manufacturer, bvm manual resuscitation systems with alternative directional valves configuration positioned on the ‘back plate’ are not affected by this fsn and are safe to use. affected users are instructed to quarantine and stop the use of all affected devices. if no suitable replacement is available, users should check the orientation of the valves on the back plate of the self-inflating bag and ensure they are orientated correctly. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-2-to-5-january-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 january 2018.