MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SIEMENS MEDICAL SYSTEMS CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number DEFINITION AS 128

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 09/22/2021

Event Type  Injury  

Event Description

Patient's fingers were caught in between ct table and the bed which resulted in deep lacerations to the patient's fingers.Treated in the ed.The ct in question was removed from service.Siemens medical was alerted to the incident.Siemens medical engineer arrived (b)(6) 2021 and evaluated the ct in question.Siemens engineer found no defects in the operation of the ct in question.The ct was cleared for continual use by the siemens engineer.Fda safety report id# (b)(4).

• Brand Name: SIEMENS MEDICAL SYSTEMS CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; malvern PA 19355
• MDR Report Key: 12540454
• MDR Text Key: 273819265
• Report Number: MW5104238
• Device Sequence Number: 1
• Product Code: JAK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DEFINITION AS 128
• Device Catalogue Number: 08098027
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR