heartstart mrx monitor/defibrillators 의 안전성 경고

Safety alert

2014-02-26

2014-02-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140226a.html

Medical device safety alert: philips heartstart mrx monitor/defibrillators medical device manufacturer, philips healthcare, has issued a field safety notice concerning heartstart mrx monitor/defibrillator. the affected model numbers and serial numbers are as follows: m3535a: us00100104 - us00572207 m3536a: us00100902 - us00543688 m3536j: us00209838 - us0332675 m3536m: us00500002 - us00500009 m3536mc: us00500002 - us00500028 when used in hospital transport and pre-hospital environments, the connection between the pads/paddles therapy cable (including pads cpr therapy cable, external paddles cable, and internal paddles cable/adapter) and the mrx therapy connection port could experience high levels of stress causing accelerated wear. wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. this wear could also cause the affected product to inappropriately identify the pads therapy cable, external paddles, or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers. the manufacturer will arrange inspection of the affected units and install a stabilizing collar if necessary. the manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 february 2014.