MAUDE Adverse Event Report: PHILIPS INDIA LTD. BV ENDURA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BV ENDURA
Medical Device Problem Codes	No Display/Image (1183); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the screen went black during use.The device was in clinical use at the time of the event.No harm has been reported.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information acquired, the system displayed a black screen and image distortion.This issue occurred at the beginning of a diagnostic procedure, which was rescheduled.A philips field service engineer (fse) inspected the system on site and identified a faulty stand trolley cable.After replacing the stand trolley cable, the system was returned to use in good working order.Re-evaluation of the reported event has led to the determination that this complaint is not reportable.The reported issue did not lead to a death or a serious deterioration in the state of health of a patient, user or other person and based on historical data it's unlikely to do so were it to recur.Based on re-evaluation, philips concludes that the complaint is not reportable.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information acquired, the system displayed a black screen and image distortion.This issue occurred at the beginning of a diagnostic procedure, which was rescheduled.A philips field service engineer (fse) inspected the system on site and identified a faulty stand trolley cable.After replacing the stand trolley cable, the system was returned to use in good working order.Re-evaluation of the reported event has led to the determination that this complaint is not reportable.The reported issue did not lead to a death or a serious deterioration in the state of health of a patient, user or other person and based on historical data it's unlikely to do so were it to recur.Based on re-evaluation, philips concludes that the complaint is not reportable.The codes were updated based on the investigation outcome.Health impact code and device problem code were corrected the product udi, reporting institution name, reporting address line 1 and the reporting address city have been updated.

• Brand Name: BV ENDURA
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer (Section G): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17781232
• Report Number: 3003768277-2023-05196
• Device Sequence Number: 12406322
• Product Code: OWB
• UDI-Device Identifier: 00884838055490
• UDI-Public: (01)00884838055490
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: BV ENDURA
• Device Catalogue Number: 718075
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 10/09/2023; 10/09/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/13/2023; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown