MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Device Problems Mechanical Problem (1384); Failure to Read Input Signal (1581); Use of Device Problem (1670)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Prior to incision time of procedure, siemens system for hybrid or was on and operating as expected.Shortly after incision time, siemens system would not move with controls.Attempted to turn off and turn on system, allowing it to reboot.However, siemens system would not respond to controls to move.Eventually, siemens system did become fully operational and procedure was completed.However, having these problems with siemens system caused a significant delay.

• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevardv; malvern PA 19355
• MDR Report Key: 15931489
• MDR Text Key: 304984423
• Report Number: 15931489
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2022
• Date Report to Manufacturer: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA