MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBIDIAGNOST R90; TABLE, RADIOLOGIC

Model Number 709030

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Int.Ref.(b)(4).The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

The customer complained about the system power distribution unit (in short named spdu) produced a significant amount of smoke.Hospitals smoke sensor was activated and the fire department was involved.No patient involvement.

Manufacturer Narrative

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.That lead to that the mains was disconnected to the transformer before the firefighter disconnected the whole room.Philips field service engineer replaced the transformer and activated the thermo switch by removing the short wire.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.

• Brand Name: COMBIDIAGNOST R90
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 8883839
• MDR Text Key: 154120695
• Report Number: 3003768251-2019-00012
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 00884838076747
• UDI-Public: (01)00884838076747
• Combination Product (y/n): N
• PMA/PMN Number: K163210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 709030
• Device Catalogue Number: 709030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1328-2020
• Patient Sequence Number: 1