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

Model Number 10430603

Device Problems Crack (1135); Use of Device Problem (1670)

Patient Problem Abrasion (1689)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a siemens employee.The reporting facility telephone number is (b)(6).Siemens has completed a technical investigation of the reported event.The root cause of the event is user error which resulted in the gantry cover and plexi-ring being slightly cracked due to the external force of the patient's leg prosthetic(s) colliding with the gantry cover.The siemens service engineer examined the system and reported that the gantry cover had sustained only minimal damage and that the system was safe to use after the event.The damaged components will be replaced by siemens pending clarification from the customers system insurance.No further action is warranted at this time.

Event Description

It was reported to siemens that prior to a ct chest examination with the somatom definition flash system, the patient, whose health was described as unstable at the time of the examination and whose legs had been amputated below the knee (date unknown), was positioned on the patient table with the legs positioned in a nearly vertical position.This was due to the patient's legs having stiffened and being severely contracted (patient was unable to be positioned with legs horizontal to the patient table).It was also reported that the patient had a steel prosthetic or prosthetics on one or both of his legs at the time of the exam.Despite the user having reportedly checked the patient's leg position for gantry clearance, the patient's leg prosthetic(s) collided with the gantry during table movement at the end of the ct scan.This resulted in a broken gantry cover and plexi-ring.The patient sustained mild abrasion injury to the knee(s).According to the report no additional injuries were sustained aside from the mild abrasions.The ct scan was completed.The reported event occurred in (b)(6).

• 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: 10663140
• MDR Text Key: 219181860
• Report Number: 3004977335-2020-47224
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2020
• 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