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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVENTIONAL WORKSPOT; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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INTERVENTIONAL WORKSPOT; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number INTERVENTIONAL WORKSPOT
Medical Device Problem Code Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/02/2021
Type of Reportable Event Malfunction
Event or Problem Description
It has been reported to philips that during an emergency procedure for a stroke patient, the customer was not able to use the xperct functionality of the system.The procedure was completed using regular ct.No harm to the patient or user has been reported to philips.Philips has started an investigation for this complaint.
 
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the information collected, when starting the xperct scan a user message was shown indicating a problem with the xtravision connection.Philips analyzed the log files of the xtravision and the allura system, which concluded that the problem was caused by a failed dicom association that caused 3d acquisitions being blocked.The problem was resolved by rebooting the xtravision workstation.No similar complaints have been identified.
 
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Brand Name
INTERVENTIONAL WORKSPOT
Common Device Name
SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
MDR Report Key11147367
Report Number3003768277-2021-00006
Device Sequence Number836771
Product Code LLZ
UDI-Device Identifier00884838059191
UDI-Public00884838059191
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K181177
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
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
Operator of Device Health Professional
Device Model NumberINTERVENTIONAL WORKSPOT
Device Catalogue Number001000
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date01/02/2021
Initial Date Received by Manufacturer 01/02/2021
Supplement Date Received by Manufacturer01/02/2021
Initial Report FDA Received Date01/11/2021
Supplement Report FDA Received Date05/18/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured11/09/2012
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Patient Age38 YR
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