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

Model Number 8098027

Device Problem Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Laceration(s) (1946)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

Reporting facility phone number is: (b)(6).A facility contact name was not provided and the event was reported by a siemens employee.Siemens will submit a supplemental report in the event new information becomes available.

Event Description

It was reported to siemens that a moderate hand injury was sustained by a patient during an examination using the somatom definition as system.The injury occurred when the patient table was moved, and the patient's hand was trapped in the moving table parts.The patient sustained a large, horizontal laceration to the top of the right hand and sutures were required to close the wound.The patient's top of the patient's hand and lower portions of the fingers were also bruised.Siemens was informed that the user did not fixate the patient's arms as recommended by the manufacturer.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11695332
• MDR Text Key: 246313080
• Report Number: 3004977335-2021-74163
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• 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,foreig
• Type of Report: Initial
• Report Date: 04/20/2021

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: 8098027
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention