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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K
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IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K Back to Search Results
Model Number EVO4K220
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that during return testing, it was observed that the screen on the image management system- evolution 4k device was black.There was no procedure nor patient involvement reported.No additional information was provided.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.It was reported that the screen of a image management system- evolution 4k is black.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: ¿ minor scratches on the unit.¿ service : software upgrade the software was upgraded to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.H10 correction narrative: d9: the date device returned to manufacturer was inadvertently missed on the initial report; and has been updated to reflect the correct information.
 
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Brand Name
IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K
Type of Device
IMAGE MANAGEMENT
MDR Report Key11825366
MDR Text Key253482673
Report Number1221934-2021-01557
Device Sequence Number1
Product Code MQB
UDI-Device Identifier00817613020543
UDI-Public00817613020543
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 05/03/2021
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
Device Operator Health Professional
Device Model NumberEVO4K220
Device Catalogue Number242326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Initial Date Manufacturer Received 05/03/2021
Initial Date FDA Received05/14/2021
Supplement Dates Manufacturer Received06/03/2021
07/29/2021
Supplement Dates FDA Received06/04/2021
07/29/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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