MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM SCOPE POWER (DE); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10046799

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Reporting facility phone number and contact name were not provided to siemens.The event was reported by a siemens employee.Siemens performed technical evaluation of the reported event and system.The plexi-ring had aged and had become brittle, requiring a replacement which was performed.The system user manual cautions against performing maintenance and other tasks while the gantry is in motion.The root cause is use error.No device malfunction or general design were identified.

Event Description

It was reported to siemens that the plexi-ring of the ct gantry cover has jumped out of its track due to a missing/broken plastic lock.The facility technician attempted to push the plexi-ring back into its original position but did not wait until the gantry stopped rotating.The technician's finger got caught in the rotating parts and a moderate injury to the digit was sustained.It was reported that both the skin and muscle of the digit were injured.The injury was treated by suturing the laceration.There was no permanent damage to the technician's finger.This incident is considered a work accident and no malfunction or general design issue were reported.The reported event occurred in (b)(6).

• Brand Name: SOMATOM SCOPE POWER (DE)
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11715155
• MDR Text Key: 246966313
• Report Number: 3004977335-2021-74648
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869013053
• UDI-Public: 04056869013053
• Combination Product (y/n): N
• PMA/PMN Number: K183548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/22/2021

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: 10046799
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention