Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 728306
Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Data Problem (3196)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that while performing a patient bolus tracking procedure, the heart rate (hr) display on the gantry panel and the scanned hr were different by 10 beats.The philips field service engineer (fse) reported that there was no harm to a patient, operator or bystander.The fse confirmed the gantry panel displayed a hr of 79 and reported that the maximum dosage of beta blocker was administered to the patient to reduce the hr, however, the gantry panel still displayed a hr of 79.The fse stated the operator chose to complete the patient acquisition and the resulting images displayed a heart rate of 69, which was a difference of 10 beats that was displayed on the gantry panel.
 
Manufacturer Narrative
(b)(4).On (b)(6) 2015, (b)(6) reported that the patient heart rate (hr) indicated on their philips brilliance ict was higher than the patients actual heart rate.The customer indicated that during a bolus tracking procedure and after performing the surview, the operator checked the patient's hr indicated on the gantry panels.The hr displayed on the gantry panels was 79 beats per minute (bpm).The operator felt that the patient's hr was too high to attain the desired image quality (iq) and administered a beta blocker to lower the patient's hr.After administration of the beta blocker, the patients hr was not reduced.The operator administered the maximum allowable dose of beta blocker; however, the patient's hr did not change.The operator chose to perform the procedure with the indicated hr of 79 bpm.After the procedure was completed, the patient's indicated hr began to lower until it reached 69 bpm.The customer cycle powered on the system and then contacted the philips help desk for assistance.A philips field service engineer (fse) was dispatched to the site.The fse connected the electro cardio graph (ecg) tester to evaluate the system.The fse also evaluated the system log files.The fse determined that the patient's hr had not been refreshed on the system since 5 minutes before the study was started.The fse forwarded the gathered data to engineering for further evaluation.Engineering was able to reproduce this defect by slowly changing the heart rate over a period of time and not seeing the hr display change on the panels.The engineering investigation found that the crtc (cardiac real time component) has a line of software code where the heart rate is not updated unless the average heart rate from the last 3 r-r waves is greater than +/- 1 bpm from the previous average.This means that if the average heart rate changes between 1 bpm up or 1 bpm down, the heart rate display on the gpc (gantry personal computer) and the console will not change.After engineering performed system testing, it was determined that the fastest the heart rate changes without it being updated is about 12bpm in 12 seconds.Upon further investigation, it was discovered that when the hr changes very slowly, the display will not be updated at the required rate for informational purposes.This finding is for the hr display only and does not impact cardiac performance in any way.It was confirmed that by pulling the ecg cables off or disconnecting the patient information monitor (pim) and reconnecting everything, it will correct this issue.Also, this defect does not affect cardiac scanning.It only affects the heart rate display value.The ifu cardiac guide v4 for ict states (under ecg viewing) that the ecg shown on the gantry is not to be used for diagnosing patient condition.The customer used the heart rate information for purposes that were outside of the use specified by the cardiac guide.Ct engineering determined this issue to be an acceptable risk and if the malfunction were to recur it would not be likely to cause or contribute to death or serious injury because: ¿ warning in the instruction for use that the ecg viewer in the operator host is only for reconstruction process.The crtc (cardiac real time component) has a line of software code where the heart rate is not updated unless the average heart rate from the last 3 r-r waves is greater than +/- 1 bpm from the previous average.This means that if the average heart rate changes between 1 bpm up or 1 bpm down, the heart rate display on the gpc (gantry personal computer) and the console will not change.
 
Event Description
The customer reported that while performing a patient bolus tracking procedure, the heart rate (hr) display on the gantry panel and the scanned hr were different by 10 beats.The philips field service engineer (fse) reported that there was no harm to a patient, operator or bystander.The fse confirmed the gantry panel displayed a hr of 79 and reported that the maximum dosage of beta blocker was administered to the patient to reduce the hr, however, the gantry panel still displayed a hr of 79.The fse stated the operator chose to complete the patient acquisition and the resulting images displayed a heart rate of 69, which was a difference of 10 beats that was displayed on the gantry panel.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ICT
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
595 miner rd
cleveland OH 44143
Manufacturer Contact
nancy drake
595 miner rd
cleveland, OH 44143
4404833000
MDR Report Key4932530
MDR Text Key22638430
Report Number1525965-2015-00204
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number728306
Device Catalogue NumberNCTC780
Device Lot Number100079
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/24/2015
Initial Date FDA Received07/22/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-