MAUDE MDR 3927166

MDR report key
3927166
Report number
MW5037128
Event key
0
Event type
3
Date of event
2014-06-06
Date received
2014-07-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRAGERANESTHESTIC RECORD EHR SYSTEMDRAGEROFPTF-ONYX-1755DT-C1-1110 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-020

Event Narratives#

D

Patient 1

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).