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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRILLIANCE ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BRILLIANCE ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number BRILLIANCE ICT
Device Problem Unintended System Motion (1430)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2020
Event Type  malfunction  
Manufacturer Narrative
We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.
 
Event Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that while positioning the patient support in the vertical direction during clinical use, the patient support descended down uncontrolled to the lowest position.Based on the available information, this issue has been initially determined to be a reportable event.
 
Manufacturer Narrative
The customer, (b)(6), reported that while positioning the patient support couch in the vertical direction during clinical use, the patient support descended down uncontrolled to the lowest position.There was no report of harm.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The fse reviewed logiles which confirmed that the patient support descended down about 20 centimeters.The couch was at its lowest position therefore no further testing could be performed.To resolve the issue, the fse replaced the drive screw for vertical movement: ball screw; ball bearing service; corner, pedestal covers.The failed parts were sent to philips engineering for failure analysis.Failure analysis determined the couch dropped due to a ball screw fracture at the journal side.The fracture was caused by fatigue failure due to misalignment between the motor shaft and ball screw journal.Probably cause: fatigue failure due to misalignment between the motor shaft and ball screw journal.Based on engineering's investigation, the overall residual risk is determined to be acceptable.The following caution is included in current information for users: the philips systems should not be used if any of the following contraindications exist or are thought to exist.The image performance quality assurance checks listed under the heading, maintenance, have not been satisfactorily completed.The preventative maintenance program is not up-to-date.If any part of the equipment or system is known (or suspected to be) operating improperly.There is no additional disclosure of residual risks to users necessary because the current information for users would have the user stop use and contact service in the case of suspected problems.Therefore, based on the investigation conclusion, this issue has been determined not to be a reportable event.
 
Event Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that while positioning the patient support in the vertical direction during clinical use, the patient support descended down uncontrolled to the lowest position.Based on the available information, this issue has been initially determined to be a reportable event.
 
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Brand Name
BRILLIANCE ICT
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best 5684 PC
NL  5684 PC
MDR Report Key10113985
MDR Text Key194015358
Report Number3015777306-2020-00002
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K162838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBRILLIANCE ICT
Device Catalogue Number728306
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date05/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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