BRILLIANCE AIR 40/64/UCT 728231

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for BRILLIANCE AIR 40/64/UCT 728231 manufactured by Philips Medical Systems (cleveland), Inc..

Event Text Entries

[188257235] Reporting determination: this complaint has been evaluated based on the information provided; there is no allegation of death or serious injury. The issue reported was that the couch had descended to its lowest limit uncommanded with a patient on it. The couch was about one meter off the ground when this occurred. The patient left the ct department with a complaint of back pain and was pending a doctor assessment. Based on the available information, this issue has been initially determined to be a reportable event. Therefore, this complaint is considered to be a reportable event to the regulatory agency per ha198-004-00 adverse event reporting procedure (ct/nm). This issue is not a reportable radiation event per ha198-005-00 ct/ami radiation event reporting.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1525965-2020-01000
MDR Report Key9887862
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Event2020-03-02
Date Facility Aware2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DERRICK MASSURI
Manufacturer Street595 MINER ROAD
Manufacturer CityCLEVELAND OH 44143
Manufacturer CountryUS
Manufacturer Postal44143
Manufacturer G1PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
Manufacturer Street595 MINER ROAD
Manufacturer CityCLEVELAND OH 44143
Manufacturer CountryUS
Manufacturer Postal Code44143
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRILLIANCE AIR 40/64/UCT
Generic NameSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Product CodeJAK
Date Received2020-03-27
Model Number728231
Catalog Number728231
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
Manufacturer Address595 MINER ROAD CLEVELAND OH 44143 US 44143


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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