MAUDE Adverse Event Report: SIEMENS SIEMENS SIRESKOP SD; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 8890415

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Pain (1994)

Event Date 03/07/2018

Event Type  malfunction  

Event Description

Patient was standing on the footboard of siemens sireskop sd table.The patient was positioned at approximately 45 degree angle.A screw popped out and the footboard detached causing the patient to fall to the floor.The patient experienced pain.No other acute injury noted.Event occurred during ugi exam.

• Brand Name: SIEMENS SIRESKOP SD
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS
• MDR Report Key: 7344756
• MDR Text Key: 102833971
• Report Number: MW5075909
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8890415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 120