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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTEGRIS ALLURA 15 & 12 (MONOPLANE); INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS HEALTHCARE INTEGRIS ALLURA 15 & 12 (MONOPLANE); INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722043
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 04/16/2019
Event Type  Death  
Manufacturer Narrative
When the investigation has been completed philips will inform the fda.
 
Event Description
It has been reported to philips that during angioplasty procedure, the arc stopped to work and no x-ray was possible.After that, the patient had a cardiac arrest.The team did the resuscitation and the patient went to icu, dying in the next day.Philips has started an investigation for this complaint.
 
Event Description
It has been reported to philips that during angioplasty procedure, the arc stopped to work and no x-ray was possible.After that, the patient had a cardiac arrest.The team did the resuscitation and the patient went to icu, dying in the next day.
 
Manufacturer Narrative
Philips has investigated this complaint.The patient arrived at the hospital suffering from a heart attack.When use of the x-ray system was required for angioplasty, no x-ray was possible.Philips has confirmed with the hospital staff that the heart attack evolved into cardiac arrest requiring different treatment and therefore procedure was aborted.The hospital staff performed resuscitation, the patient was moved to the icu and then passed away the next day.Analysis of the log files showed that the reason that no x-ray was possible was that the system performed an automatic warm restart due to a communication issue between the geometry (x-ray system) and the system coordinator component.The warm restart did not solve the issue and the user performed a cold restart.This cold restart was unsuccessful because a button on the table side operating module was activated during the restart process, which caused an error.The user then performed a second cold restart of the system after which the system started working as per specifications.The log files indicate that system movements and x-ray were available again after approximately 13 minutes.The log files do not provide further details to identify the exact root cause of the communication issue.The customer has been requested to perform electrical grid testing to exclude issues with the hospital electrical network.The customer did not do this so far.Philips has proactively replaced three relays in the communication network.The customer has not reported a reoccurrence of the issue.Philips has checked the preventive maintenance records from 2018 until april 2019, which showed that all the system parameters were within specification.Analysis of service requests placed from 2018 to date for this system did not identify any similar issues.The hospital has declined to share further patient information due to patient confidentiality.A search in the complaint database did not show any similar complaints.No further actions will be taken by philips.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
INTEGRIS ALLURA 15 & 12 (MONOPLANE)
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL  5680 DA
MDR Report Key8615459
MDR Text Key145232367
Report Number3003768277-2019-00040
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K002016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722043
Device Catalogue Number722043
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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