MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Patient was unable to be tilted into preferred position for procedure.Patient was intubated for approximately 20 minutes while efforts were made to correct malfunction.Siemens representative arrived at close of case.Manufacturer response for siemens or bed, (brand not provided) (per site reporter): siemens rep was brought to review the bed functioning.

• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 6653059
• MDR Text Key: 77933095
• Report Number: 6653059
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

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: Nurse
• Other Device ID Number: 10502018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR