MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ONCOR IMPRESSION PLUS; ACCELERATOR, LINEAR, MEDICAL

Model Number 5857912

Device Problems Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problems Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

The original initial report was submitted on 04/28/2016 as mfr report #2240869-2016-40289.Siemens' investigation of customer log files provided shows that the event occurred due to an incorrect character typed in table coordinates by the user.The user manual warns the user to observe patients and system movements to prevent injuries.Considering the outcome of the investigation, no corrective action is initiated.

Event Description

Siemens was informed on april 19, 2016 by the customer that the patient was squeezed between the gantry and table due to a typo in table coordinates.Reportedly, the user operated the table remotely from the control console.A typo in table coordinates resulted in an upward, vertical table movement toward the gantry, which the user initiated by keeping the f12, alt and enable keys pressed down and did not release them.The patient collided with the accessory holder that was attached to the gantry.The patient suffered a broken rib and was hospitalized for one day in the intensive care unit.However, there is no information as to the patient's status at this time.This reported event occurred in (b)(6).

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 8566677
• MDR Text Key: 143613385
• Report Number: 3002466018-2016-40289
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5857912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: LINAC ACCESSORY
• Patient Outcome(s): Required Intervention