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

Model Number 10430603

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has initiated a technical investigation of the reported event.The root cause has not been identified.A supplemental report will be submitted upon the completion of the investigation.

Event Description

It was reported to siemens that the bed rail used for the system accessories fell off and hit the patient's lower body (legs).The patient sustained moderate injuries which required medical treatment, however, the details regarding the type of injuries, medical treatment provided, and patient's current health status were not provided to siemens as of the date of this report.

Event Description

Additional event information and clarification: additional information from the facility reported that an assisting person, not the patient, who was slightly injured during the reported event.The injured assistant was offered medical treatment but declined.The patient's assistant was helping the patient off the table to a stretcher and the stretcher was caught under the table as the table was being lowered, causing the side rail of the table to break off.The side rail fell onto the assistant's foot.

Manufacturer Narrative

Manufacturer narrative: h3; h4: siemens completed the technical investigation of the reported event.The root cause of the event was use error due to the stretcher being positioned under the table as it was being lowered.This resulted in the side rail being broken off and falling.Clinical engineering repaired the side rail and the table is now functional.Additional action is not warranted at this time.

• Brand Name: SOMATOM DEFINITION FLASH
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10683118
• MDR Text Key: 216595494
• Report Number: 3004977335-2020-48403
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention