MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM LUMINOS DRF; IMAGE-INTENSIFIED FLUROSCOPIC X-RAY

Model Number 10094200

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2014

Event Type  malfunction  

Event Description

It was reported that while performing a service call on the axiom luminos drf system siemens service engineer noticed a loose gear on the motor shaft m80.The gear was adjusted manually by narrowing the shaft's screw; no part replacement was required.There are no injuries attributed to the event.The reported event occurred in brazil.

Manufacturer Narrative

The issue was resolved at the site by siemens engineer.The reported issue is under investigation and a supplemental report will be submitted once additional information has been received.Customer's address: (b)(6).

Manufacturer Narrative

The investigation of the reported event was completed by siemens experts.The investigation of the loose gear-wheel on a test system showed that loosening of the grub screw does not result in loosening of the chain wheel from the drive shaft.The chain wheel can only shift minimally in lateral direction.Therefore, no safety risk is associated with the reported issue.The reported event was complaint was reclassified to a non-safety related matter after the investigation was completed.The chain wheel on the customer system was adjusted by siemens local service.Siemens is now aware of the reported event being a general problem.

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED FLUROSCOPIC X-RAY
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy, ms d-02; malvern PA 19355 1406
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy, ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4554504
• MDR Text Key: 21238005
• Report Number: 2240869-2015-00699
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/30/2015

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: 10094200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other