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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INTERVENTIONAL WORKSPOT SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INTERVENTIONAL WORKSPOT SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number INTERVENTIONAL WORKSPOT
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2021
Event Type  malfunction  
Event 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.
 
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Brand NameINTERVENTIONAL WORKSPOT
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best 5684 PC
NL 5684 PC
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 4-6
best 5684 PC
NL 5684 PC
Manufacturer Contact
dusty leppert
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key11147367
MDR Text Key226050728
Report Number3003768277-2021-00006
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181177
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberINTERVENTIONAL WORKSPOT
Device Catalogue Number001000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/02/2021
Event Location No Information
Date Manufacturer Received01/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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