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

Model Number	709030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
The customer complained about a burning smell from the system.No injury occurred.
Additional 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.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.

• Brand Name: COMBIDIAGNOST R90
• Common Device Name: TABLE, RADIOLOGIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 9166537
• Report Number: 3003768251-2019-00018
• Device Sequence Number: 16634342
• Product Code: JAA
• UDI-Device Identifier: 00884838076747
• UDI-Public: (01)00884838076747
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K163210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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 Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z 1328 2020
• Patient Sequence Number: 1