MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH UROSKOP ACCESS R; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 5756130

Device Problems Mechanical Problem (1384); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

When the doctor went to use the x-ray machine/x-ray bed to check for a stone, the machine would not come on and function properly.There was no harm to the patient.Biomet was notified so they can work on it.The pt.Was transferred to cystoscopy room 2 for the completion of his procedure.

• Brand Name: UROSKOP ACCESS R
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 9278705
• MDR Text Key: 165059867
• Report Number: 9278705
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5756130
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29930 DA