MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; SYSTEM, X-RAY, FLUOROSCOPIC

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Event Description

When the procedure started and the physician stepped on fluoroscopy, the image would not show on the screen.The system was then re-booted and the problem was not resolved.The patient was then moved.The situation was explained to the patient.There was no harm to the patient and philips was notified.No further identifying information is available at this time.There was no harm to the patient.

• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner road; cleveland OH 44143
• MDR Report Key: 8023322
• MDR Text Key: 125640097
• Report Number: 8023322
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2018

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
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA