Heartstart MRx Defibrillator/Monitor 의 안전성 경고

Safety alert

2014-12-05

2014-12-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141205.html

Medical device safety alert: philips medical systems heartstart mrx defibrillator/monitor health canada posted a medical device safety alert concerning heartstart mrx defibrillator/monitor, manufactured by philips medical systems. according to the fsn from the manufacturer, the affected devices are heartstart mrx monitors/defibrillators having etco2 option and/or old cap plate with the followings: model numbers: a) m3535a, b) m3536a, c) m3536m, d) m3536mc, e) m3536m4, f) m3536m5 serial numbers: a) us00100100 - us00552845; b) us00100902 - us00552848, c) us00500002 to us00501201; d) us00500001 to us00500087; e) us00500003, us00500004, us00552673, us00552678, us00552679; f) us00500001 to us00552801 the manufacturer has become aware that the heartstart mrx defibrillator/monitor can be susceptible to one or both of the issues described below:- the co2 inlet port associated with end-tidal carbon dioxide (etco2) monitoring on mrx monitor/defibrillators can be pushed into the mrx housing, making it inaccessible. this can occur if the user attempts to push the co2 filter line fitting into the inlet port, instead of twisting it clockwise as described in the mrx instructions for use. the handle can separate from the mrx housing due to breakage of mounts on the rear case. if the co2 inlet port can no longer be accessed, the user will be unable to initiate etco2 monitoring when needed. separation of the handle from the mrx housing can cause the mrx to fall, potentially injuring the patient or user. in addition, a delay of therapy could occur if the device is damaged by the impact. the co2 filterline fitting should not be forced into the co2 inlet port. rather, after inserting the filterline fitting into the port, the fitting should be turned clockwise to secure into place, per the mrx instructions for use. if the inlet port becomes inaccessible during use, continue to treat the patient according to their organization’s protocol. if one or both sides of the handle are found to have separated from the mrx housing, continue to treat patients per existing protocols. do not use the handle to carry the mrx. the mrx can be carried in another manner. for example, the mrx shoulder strap or bed rail hook can be used if available on the unit. the manufacturer will provide hardware upgrade for all affected units and will contact customers with affected devices to arrange for installation of the upgrade. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to the following health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/42779r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 december 2014.