MAUDE Adverse Event Report: GE HEALTHCARE; CARDIO LAB COMPUTER SYSTEM

Device Problems Use of Device Problem (1670); Connection Problem (2900); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2021

Event Type  malfunction  

Event Description

Patient was placed on the procedure table and intubated.The cardio lab computer system was unable to connect to the server possibly due to a power loss over the weekend.It resulted in a 20 min delay of care.This is a carry over from the monitoring issues from the weekend.Ups (uninterruptible power supply) failed for the server which caused the issue.Issue was corrected and is being investigated by biomed to prevent future incidents.

• Type of Device: CARDIO LAB COMPUTER SYSTEM
• Manufacturer (Section D): GE HEALTHCARE; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 12646923
• MDR Text Key: 276878291
• Report Number: 12646923
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Date Report to Manufacturer: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1