MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PROXIDIAGNOST N90; SYSTEM, X-RAY, STATIONARY

Model Number	706100
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref.Id: (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
While the system was being used for a fluoroscopy study, the mains cabinet started making loud popping sounds along with sparking, smoking, and an electrical fire inside of the cabinet.Nobody was injured.
Additional Manufacturer Narrative
Ref.Id: (b)(4).The proxidiagnost system is a stationary nearby-controlled system supports general radiography and fluoroscopy imaging.The system is connected to the hospital main power supply.To adapt the voltage to the hospital power supply, the system is equipped with a spdu (system power distribution unit).This spdu transforms the voltage and eliminate spikes.Therefore the spdu contains a line-filter.On this filter are varistors that protects the system against overvoltage.In case of overvoltage the varistors made a short circuit or cut the connection.In case of a short circuit the varistor are designed to thermally self-destruct.The field service engineer investigated on site and confirmed the issue.He found that the line filter of the spdu caused this issue.A capa investigation leads to a field safety correction.Correction: h6 result and conclusion.The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.
Additional Manufacturer Narrative
Ref.Id: (b)(4).The proxidiagnost system is a stationary nearby-controlled system supports general radiography and fluoroscopy imaging.The system is connected to the hospital main power supply.To adapt the voltage to the hospital power supply, the system is equipped with a spdu (system power distribution unit).This spdu transforms the voltage and eliminate spikes.Therefore the spdu contains a line-filter.On this filter are varistors that protects the system against overvoltage.In case of overvoltage the varistors made a short circuit or cut the connection.In case of a short circuit the varistor are designed to thermally self-destruct.The field service engineer investigated on site and confirmed the issue.He found that the line filter of the spdu caused this issue.A capa investigation leads to a field safety correction (fco70600105).Philips field service engineer installed the field safety correction.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.

• Brand Name: PROXIDIAGNOST N90
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 16313564
• Report Number: 3003768251-2023-00002
• Device Sequence Number: 5759014
• Product Code: JAA
• UDI-Device Identifier: 00884838085619
• UDI-Public: 00884838085619
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K173433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup

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: 706100
• Device Catalogue Number: 706100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021; 02/16/2021
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/09/2023; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1356-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown