MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CIC PRO; DETECTOR AND ALARM, ARRHYTHMIA

Model Number MP100D

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

Power supply in the ge all in one monitor burnt out, second time in about 1 year.There is another like item that is happen to in the past as well but did not think much of it until now that it happened again on another monitor.Manufacturer response for central station, ge (per site reporter).The first time this happened they came out and replace the power supply and that was it.Since then we have been replacing it ourselves.

• Brand Name: CIC PRO
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 8200 west tower ave; milwaukee WI 53223
• MDR Report Key: 11884647
• MDR Text Key: 252664365
• Report Number: 11884647
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MP100D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1