MAUDE Adverse Event Report: GE HEALTHCARE GE HEALTHCARE; DATA INTERFACE UNIT - CIC

Model Number MAS700

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/13/2018

Event Type  malfunction  

Event Description

Data interface unit (cic) for ge at the centralized telemetry froze up, not allowing the nurse/tech to click or perform any action on the display.Not able to admit, review, or access anything on the display.Staffs were not able using the mouse or the touch screen.Once the device was restarted, it came back up and worked normally.Per site reporter: no answer from ge healthcare yet.

• Brand Name: GE HEALTHCARE
• Type of Device: DATA INTERFACE UNIT - CIC
• Manufacturer (Section D): GE HEALTHCARE; 3000 n grandview blvd w-450; waukesha WI 53188
• MDR Report Key: 7800479
• MDR Text Key: 117700245
• Report Number: 7800479
• Device Sequence Number: 1
• Product Code: DXN
• 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: 08/16/2018

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: Health Professional
• Device Model Number: MAS700
• 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: 08/16/2018
• Device Age: 9 MO
• Date Report to Manufacturer: 08/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36135 DA