Health Canada — Medical Devices · Canada · 2016-08-05 · Type III
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Reported risk: Notification related to a potential risk for warning lamp connectors and/or chiller grounding discontinuity. Manufacturer identified during in-house testing a potential ground discontinuity in sub-assemblies, leading to potential risk of user electrical shock upon direct contact with these sub-assemblies. Risk of user electrical shock was low. In addition the system residual risk levels did not change and remained acceptable. Manufacturer also determined that there was no change in risk to the patient since the assemblies were located outside the OR.
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