MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MULTITOM RAX; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10860700
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction of the multitom rax could be identified.There are several possibilities to measure the size of an anatomic structure: performing measurements with a ruler, using table object distance (tod) functionality, true size application.In addition, it is recommended to have at least two x-ray images taken for precise measurement.Then available methods for working with projection images should be applied by physician to avoid the described incident.The initial issue was first related to the pacs, however, november 18th., the manufacturer became aware that the customer considers the issue to be related to the use of the multitom rax system, therefore, re-evaluation of reportability was performed.Internal id # (b)(4).
Event or Problem Description
Siemens became aware of an incident that occurred on the multitom rax unit.The user reported that a surgical intervention could not be completed and an implant could not placed due to incorrect measurements of a tibia implant shown on x-ray images.An image was not scaled with "real size" when viewing in pacs making tibia implant dimension too long to be inserted in a patient.The surgery had to be stopped, and the patient had to be awakened.The user had to order another implant and the surgery had to be repeated.However, no malfunction of the multitiom rax device was identified.Siemens is not aware of any injuries attributed to this event.The reported incident occurred in (b)(6).

• Brand Name: MULTITOM RAX
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10924605
• Report Number: 3004977335-2020-56212
• Device Sequence Number: 959974
• Product Code: OWB
• UDI-Device Identifier: 04056869009179
• UDI-Public: 04056869009179
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10860700
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other