MAUDE Adverse Event Report: SIEMENS AXIOM LUMINOS TF; LUMINOS TF XRAY SYSTEM

Model Number LUMINOS TF

Device Problem Date/Time-Related Software Problem (2582)

Patient Problem No Information (3190)

Event Date 04/28/2017

Event Type  Injury  

Event Description

During a routine mfr recommended procedure, the battery was changed for the realtime clock inside the generator of this x-ray system.After changing the battery in this system the date will not roll over to the following day and everyday the users are now required to update the date.The mfr claims that since the battery was changed (following their recommended procedure and time frame) now the realtime clock computer inside the generator (also known as the xcu) needs to be replaced to the tune of (b)(6) list price.My complaint is that this is a known problem when the battery is charged, why would they recommend charging this battery.If the time and date stamp on the images from this system are correct, there is a potential for medical records to be compromised.It is possible that a procedure can be "date stamped" to look like it was performed prior to an order was even placed for the exam.This is a concern for pt medical records and the mfr should be responsible for either restoring date keeping functionality to my existing room through some configuration changes, or replacement of the part.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: LUMINOS TF XRAY SYSTEM
• Manufacturer (Section D): SIEMENS; cary NC
• MDR Report Key: 6562794
• MDR Text Key: 75148467
• Report Number: MW5069715
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUMINOS TF
• Other Device ID Number: FUNCTIONAL LOCATION 400-274621
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2017
• 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