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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARCOMA AB OMNERA 400T STATIONARY X-RAY SYSTEM

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ARCOMA AB OMNERA 400T STATIONARY X-RAY SYSTEM Back to Search Results
Model Number 0180
Device Problem Misassembled During Installation (4049)
Patient Problem Insufficient Information (4580)
Event Date 03/24/2021
Event Type  malfunction  
Manufacturer Narrative
Please be informed that the reason for this report being late is that i have encountered problems regarding enrollment of the emdr program. The report was completed on april 20, 2021 but i could not submit it.
 
Event Description
A mechanical bracket for overhead tube detent (40" mark) fell from the ceiling rail during an examination.
 
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Brand NameOMNERA 400T
Type of DeviceSTATIONARY X-RAY SYSTEM
Manufacturer (Section D)
ARCOMA AB
annavägen 1
växjö, 35246
SW 35246
MDR Report Key12073574
MDR Text Key261445055
Report Number9616014-2021-00001
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
PMA/PMN Number
K140683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Repair
Type of Report Initial
Report Date 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0180
Device Catalogue Number0180
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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