MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS CT SCANNER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 128 EDGE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2019

Event Type  malfunction  

Event Description

Imaging-ct scanner was down around 01:15am sunday morning due to a cooling error.Service/repair (b)(6) site around 10am and the scanner was operational by 13:15 same date (b)(6) 2018.Fda safety report id # (b)(4).

• Brand Name: SIEMENS CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• MDR Report Key: 9465950
• MDR Text Key: 171547803
• Report Number: MW5091642
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 128 EDGE
• Is the Reporter a Health Professional?: 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): Other