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

Device Problems Failure to Transmit Record (1521); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2021

Event Type  malfunction  

Event Description

Ge medical systems (b)(6) shuts down partially without warning with patient on table.Health care providers are unable to restart auto vitals, unable to record pressures, etc.

• Brand Name: MAC-LAB
• 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: 11894201
• MDR Text Key: 252966409
• Report Number: 11894201
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2021

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Date Report to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA