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

Device Problem Loss of Power (1475)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2021

Event Type  malfunction  

Event Description

Cardiolab stopped working during ablation.Hard drive replaced.Fda safety report id# (b)(4).

• Brand Name: CARDIOLAB MAC LAB
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• MDR Report Key: 11824889
• MDR Text Key: 250838059
• Report Number: MW5101344
• Device Sequence Number: 1
• Product Code: DQK
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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 Age: 75 YR