MAUDE Adverse Event Report: DRAGER DRAGER; ANESTHESTIC RECORD EHR SYSTEM

Model Number TF-ONYX-1755DT-C1-1110

Device Problems Device Displays Incorrect Message (2591); Data Problem (3196)

Patient Problem No Information (3190)

Event Date 06/06/2014

Event Type  malfunction  

Event Description

Ge carescape monitor - innovian anesth recorded failed to record vital signs mid-case for approximately 15 minutes - i was focused on ge trend view (numeric and graphic) and did not immediately notice that recorder (or its interface) was not working properly.I have photos from ge monitor documenting that vital signs were being recorded and were trending.I have a photo documenting "no data in the rollback buffer." i have a photo documenting the time of the ge monitor was the correct time, matching innovian network time.And, i have a photo documenting the innovian system failure to record vital signs properly for the period noted above.This is a preliminary report.I have asked our department innovian rep to contact drager and see if it is possible to pull data logs, to look to see if there is an indication of some simple problem like a loose cable or other issue (innovian will show a tiny red dot in the lower right corner for connectivity issues, but as partly noted above, i was focused on the ge monitor, not the ehr - complex case requiring my full attention to the monitors, not innovian).(n.B.: serial and product numbers pulled by our technicians).

• Brand Name: DRAGER
• Type of Device: ANESTHESTIC RECORD EHR SYSTEM
• Manufacturer (Section D): DRAGER
• MDR Report Key: 3927166
• MDR Text Key: 4666917
• Report Number: MW5037128
• Device Sequence Number: 1
• Product Code: OFP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TF-ONYX-1755DT-C1-1110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1