MAUDE Adverse Event Report: MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CSCS V2 CIC; DISPLAY, CATHODE-RAY TUBE, MEDICAL

Model Number MA1700

Device Problems Thermal Decomposition of Device (1071); Loss of Power (1475); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Our healthcare organization has 20 ge healthcare cscs v2 central information centers that were all purchased in the spring of 2017 and installed on "7/21." over the past 6 months 5 of the 20 cic's power supplies have failed.When the power supply fails the cic shuts down and is no longer useable until the power supply and power entry module fuses are replaced.Once the power supply has been removed and inspected we have noticed the same large capacitor lead has burned a hole through the circuit board.During the power supply failure our telemetry technicians have noted a pungent smoke smell, hear a popping sparking sound and claim there were no messages on the cic's monitor displaying of any type of error/warning message.It's simply working one second and off the next second.Fda safety report id # (b)(4).

• Brand Name: CSCS V2 CIC
• Type of Device: DISPLAY, CATHODE-RAY TUBE, MEDICAL
• Manufacturer (Section D): MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• MDR Report Key: 12590135
• MDR Text Key: 275988519
• Report Number: MW5104456
• Device Sequence Number: 1
• Product Code: DXJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/05/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MA1700
• 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