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

Device Problems Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)

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

Event Date 11/07/2016

Event Type  malfunction  

Event Description

Cath lab reports that the mac lab monitoring equipment stopped working.Staff unable to record bp, pulse oximetry, hr and arterial line.Staff report mac lab is losing communication during patient acquisition.

• Brand Name: MAC LAB MONITORING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES; 465 pan american drive, suite 11; el paso TX 79907
• MDR Report Key: 6105472
• MDR Text Key: 59985882
• Report Number: 6105472
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.