DRAGER TF-ONYX-1755DT-C1-1110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-02 for DRAGER TF-ONYX-1755DT-C1-1110 manufactured by Drager.

Event Text Entries

[4666917] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5037128
• MDR Report Key: 3927166
• Date Received: 2014-07-02
• Date of Report: 2014-06-06
• Date of Event: 2014-06-06
• Date Added to Maude: 2014-07-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRAGER
• Generic Name: ANESTHESTIC RECORD EHR SYSTEM
• Product Code: OFP
• Date Received: 2014-07-02
• Model Number: TF-ONYX-1755DT-C1-1110
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DRAGER

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-07-02