MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARDIOLAB; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number XW-8200

Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

Patient Problems No Information (3190); No Information (3190)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

Ep system would completely shut down without warning.System rebooted and turned back on 15 minutes later, thus causing care of patient being delayed while waiting for equipment to respond.

• Brand Name: CARDIOLAB
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower avenue; milwaukee WI 53223
• MDR Report Key: 4846860
• MDR Text Key: 5942381
• Report Number: 4846860
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: XW-8200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 101