INTELLIVUE M1019A *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-03 for INTELLIVUE M1019A * manufactured by Philips Healthcare.

Event Text Entries

[861181] This has been an ongoing concern in our or's and has been affecting multiple machines. Earlier this year we introduced 12 phillips g5 intellivue anesthetic gas modules to our or's. We immediately started having issues with the g5's "locking up. " it happens in all stages during the case and even after the case when the patient has been disconnected and out of the room. It has even happened in empty rooms. The g5 led's will be flashing and the patient monitor is on "standby. " because of these concerns phillips decided to replace the original 12 machines with 12 new ones thinking perhaps we had received a bad batch. The problems have continued to the extent of phillips sending techs from germany and andover on two separate occasions to troubleshoot the issues as well as having radio frequency (rf) and power experts to look at possible environmental concerns. All of their testing shows no obvious reason for this to be happening. Our biomed tech has described the problem as: the phillips monitor displays all question marks where the information from the g5 should be displayed. The anesthesiologists don't have any co2, ino2, inn2o, etn2o readings. They lose the gas identification and all of the other necessary information. The g5 has two led's on the front (set up and standby). When we experience this problem the standby led is lit solid and the setup one flashes and is not responsive to anything but a power cycle. From having the phillips techs onsite we have discovered the g5 loses communication with the monitor and if the data cable is removed from the patient monitor for 10-15 seconds and then plugged back in the data will re-populate again. This is faster than the power cycle so when these problems occur the doctors and anesthesiologist techs have just been removing this cable and reattaching to get the data back. This problem does not affect any other information on the patient monitor such as ecg, sp02, nibp. It is just the information from the g5 gas analyzer. Phillips has indicated they feel the issue is environmental but it is so sporadic and intermittent it is difficult to determine what exactly could be causing problems.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1061681
MDR Report Key1061681
Date Received2008-06-03
Date of Report2008-06-03
Date of Event2008-06-03
Report Date2008-06-03
Date Reported to FDA2008-06-03
Date Added to Maude2008-06-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINTELLIVUE
Generic NameANESTHETIC GAS MODULE
Product CodeCCL
Date Received2008-06-03
Model NumberM1019A
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key1029370
ManufacturerPHILIPS HEALTHCARE
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 018101099 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-06-03

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