MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS AGILE MAX; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10762472

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The concerned unit was repaired by siemens local service within 2 days of operation.The unit was returned back to regular hospital operation.Internal id # (b)(4).

Event Description

Siemens was informed by its service organization that the collision protection panel of the digital imaging tower (dit) was temporarily bypassed by the user.During the time between the bypass of the device and the fix, the system remained without active collision protection.Siemens is unaware of any patient involvement.No injuries were reported in this case.

• Brand Name: LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 9569057
• MDR Text Key: 190839319
• Report Number: 3004977335-2019-13536
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2019

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: Health Professional
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other