MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC UROSKOP TABLE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problems Break (1069); Defective Component (2292)

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

Event Date 06/18/2020

Event Type  malfunction  

Event Description

Patient in cysto room on cysto table preparing to have x-ray taken for a stent placement and the machine did not work (not able to take an x-ray picture).Patient moved to the other cysto room to complete the procedure.Video card in computer failed, card replaced, tested room and working fine.Unit returned to service.

• Brand Name: UROSKOP TABLE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 10599442
• MDR Text Key: 208948181
• Report Number: 10599442
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 108