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	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the affected site the hand grip was fastened to the lowest position to avoid described incidents.Internal id # (b)(4).
Event or Problem Description
Siemens was informed that the hand grip on the multitom rax unit fell on the operator's head.It is assumed that the hand grip on the ortho stand was not attached tightly enough and, once the patient applied too much weight on the grip, it slid down causing the incident.The label on the hand grip states that no more than 30kg should be applied.The hand grip cannot fall off completely as it can slide up and down in the rail to the end point.In the reported case the user's head was in the way of the hand grip when it was sliding down.X-ray images of the user's head were taken at the facility.The user received a bump on the head.It was communicated that there was no permanent effect of the injury and no other injuries were reported to siemens.The reported event 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: 10816049
• Report Number: 3004977335-2020-53768
• Device Sequence Number: 1926371
• Product Code: OWB
• UDI-Device Identifier: 04056869009179
• UDI-Public: 04056869009179
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 11/10/2020

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: 11/02/2020
• Initial Report FDA Received Date: 11/10/2020
• 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