MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10590000

Device Problems Unintended Collision (1429); Unintended System Motion (1430)

Patient Problem No Code Available (3191)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number is (b)(6).Siemens investigated the reported event.The technical investigation revealed that during the gantry tilt, a table move button was pressed at the gantry panel, and the table movement was initiated.With this information, siemens asked the customer about the workflow during this event.It was reported that intensive care unit equipment was parked in front of the right gantry that resulted in a collision during the gantry tilt.The right gantry panel table move-button was hit by the equipment.It was determined that no device malfunction occurred.Therefore, no corrective action is deemed necessary.Additional action is not warranted at this time.

Event Description

It was reported to siemens that during a ct examination of an intubated (b)(6) weeks old infant, the table unintentionally moved the full travel distance into the gantry.According to the customer, the child was extubated as a result of the unexpected table but did not suffer any negative health consequences due to this issue.This was confirmed by a follow-up mr scan.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION EDGE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486484
• MDR Report Key: 10201447
• MDR Text Key: 199661711
• Report Number: 3004977335-2020-32481
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2020

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
• Device Operator: Health Professional
• Device Model Number: 10590000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/26/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 7 WK