MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBI DIAGNOST R90; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 709031

Device Problems No Display/Image (1183); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  Injury  

Event Description

Patient was placed on table for an arthrogram.Before the injection, the fluoro monitor in the room went black.The fluoro monitor in the control area still worked, however a re-boot of the system did not resolve the issue.Patient was moved to a different room and procedure was completed.No harm to the patient except delay in case.Room had a fco completed on it the day before - (b)(4) under philips wo (b)(4).Room was tested after the fco was completed and again the morning of the case, but when this first case was started, system failed.Unsure if this is related to the fco or the work done by philips technician (b)(4).Philips was called back in to review and resolve.Philips calibrated the monitor.Adjusted exam room monitor vga to hdmi then all monitors are functional.Tested the system returned to clinical use.Philips representative (b)(4) indicated he would follow up with nss (b)(4) to see if this calibration of the exam room monitor that muzapaer completed this morning after the room was in use, should have been done during the fco.According to (b)(4), either the fco procedure is lacking or (b)(4) missed steps.Either situation is not acceptable and philips needs to prevent this for future fco's/repairs.

• Brand Name: COMBI DIAGNOST R90
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH
• MDR Report Key: 17005209
• MDR Text Key: 316090282
• Report Number: MW5117876
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 709031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention