Alerta De Seguridad para DigitalDiagnost Patient support for stitching

Safety alert

2014-04-04

2014-04-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140404.html

Medical device safety alert: philips digitaldiagnost patient support for stitching medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its digitaldiagnost patient support for stitching. according to the manufacturer, the footboard of patient support for stitching can be fixed in upper position. when the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. if it falls down, it may hurt the operator’s or patient’s foot (e.G. when moving the stand or when the operator fails to fix it correctly upon moving the board up). the following factors are needed for the situation to occur: hook not correctly adjusted operator does not recognize that the hook does not click into place patient support is moved (wheeled around) hook does not hold foot in hazard area” the manufacturer advises users that monitors in the affected installations must not be positioned above people and that monitors must be moved with care (e.G. holding monitor in both hands) until the replacement has been carried out. in particular, monitors should not be positioned with considerable force – the stress on the lower joint of the spring-loaded arm should be minimized. the manufacturer would arrange replacement of the affected spring-loaded arm. the affected users are advised to always check the right position of the hook and that the hook is locked. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 april 2014.