Int.Ref: (b)(4).The combi diagnost r90 is a digital motorized remote controlled x ray system used for fluoroscopic and radiographic imaging.The system power distribution unit (spdu) is the main power supply for the complete system without the x ray generator.It contains a three phase transformer with a power rate of about 7kva (kilo volt ampere).Inside even of the three coils a thermo switch is installed to prevent overheating.Philips field service engineer investigated on the site and found the transformer burned and the thermo switches were without function.The thermo switches were accidentally deactivated via a pre-installed short wire (bridge) at the connection terminals at the spdu during manufacturing.The 3 phase main circuit breaker inside the spdu was found released.Philips field service engineer replaced the transformer and the control unit.After this repair the system works as specified again.A corrective action preventive action (capa) was initiated and resulted in a field safety corrective action (fco 70900045 / 70900048).After implementation of the field safety corrective action the risk is estimated as acceptable risk.This issue is further monitored and trended.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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