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

Model Number 10430603

Device Problem Break (1069)

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

Event Date 03/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens investigated the reported event and did not find evidence of device malfunction.The cause of the damage was due to the patient not being properly fastened to the table during the examination and the patient raising his knees, damaging both the shield and collimator.The investigation revealed the shield had holes broken into it and the collimator curvature was affected.Both components were replaced on (b)(6) 2019.Additional action is not warranted at this time.

Event Description

It was reported to siemens that during patient treatment using the somatom definition flash system, the patient raised his knees into the shield resulting in damage to both the shield and the collimator.The patient was cut and bruised during the event and required medical intervention.The patient was treated in the emergency room.There was no device malfunction reported and it was stated that the patient was not fastened to the table properly during the procedure.The collimator and shield were replaced.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8394603
• MDR Text Key: 137963322
• Report Number: 3004977335-2019-72384
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173630
• 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: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2019
• Date Manufacturer Received: 03/03/2019
• 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): Required Intervention